Podcasts about Merck

Just when you thought you'd heard everything about virtual fence, another podcast episode comes along. But Dr. Flavie Audoin, University of Arizona Cooperative Extension rangeland specialist, may be one of the most importance "voices" to listen to on the strengths and weaknesses of virtual fence and animal geolocation technologies. She has been in the middle of much of the early vendor comparison work as well as experimental research on animal physiology considerations and environmental applications for remote animal location detection and control. Listen to this interview to learn about the mechanisms of virtual fence options, a comparison and contrast of features on offer, and current research on graziers can better manage wild, open spaces with a back-to-the-future approach to modern herding. The Art of Range Podcast is supported by the Western Extension Risk Management Education Center, Vence (a subsidiary of Merck), and the Idaho Rangeland Resources Commission. Music by Lewis Roise. Visit the episode page at https://artofrange.com/episodes/aor-178-flavie-audoin-animal-geolocation-and-virtual-fence-technologies for the transcript of this interview and links to resources mentioned in this episode.

Dr. Monty Pal and Dr. Andrea Apolo discuss practice-changing studies and other novel approaches in bladder, kidney, and prostate cancers that were presented at the 2026 ASCO Genitourinary Cancers Symposium. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles.  And today is super exciting, we're highlighting key abstracts that were presented at the 2026 ASCO GU Cancers Symposium, and I'm just delighted to be joined by the chair of this year's meeting, who is also a dear friend, Dr. Andrea Apolo. Dr. Apolo serves within the Center for Cancer Research at the NCI as head of the Bladder Cancer Section, and she is also acting deputy chief of the Genitourinary Malignancies Branch.  Welcome, Andrea, it is so great to have you on the podcast. Dr. Andrea Apolo: Oh, thank you so much for having me. What a great ASCO that we had, it is really exciting, lots of really great data. So I look forward to chatting about it. Dr. Monty Pal: Excellent. And you know, our full disclosures are available in the transcript of this episode in case our listeners want to have a peek.  The theme of this year's GU meeting was "Patient-Centered Care: From Discovery to Delivery." I love that theme. And really, this is one of the most competitive meetings out there, more than 850 abstracts being presented on high-impact science. Andrea, I just wanted to get right into it and dive into what I think we both felt were some of the most exciting abstracts of the meeting.  And the first of those is one that I know is near and dear to your heart, being a bladder cancer expert yourself, and that is the KEYNOTE-B15 study presented by Matt Galsky. Can you give us a flavor for what that study entailed and some of the key results? Dr. Andrea Apolo: Yeah, I think this was kind of the missing study that we have been waiting for since we saw the EV-302 data in metastatic disease in the frontline setting. We wanted to know how well this combination would work in muscle-invasive bladder cancer patients. And we saw half of that puzzle, you can say half of the piece of the puzzle, when we saw the data at ESMO, the EV-303 data in patients that were cisplatin-ineligible. And then now we are getting the full story with patients that are platinum-eligible, cisplatin-eligible, with the EV-304 data. So that study randomized patients to receive chemotherapy, so different than the EV-303 where the patients were randomized just to receive the radical cystectomy. These patients were randomized to receive neoadjuvant EV plus pembro and then adjuvant EV plus pembro versus neoadjuvant gemcitabine and cisplatin with no adjuvant component to the control arm. So I think this is a really, really important study. Dr. Monty Pal: And share with us some of the results because this in my mind is definitely practice-changing. This is one of those studies that I think you walked into the office on Monday and you are like, "Okay, this is what I am doing now," right? Dr. Andrea Apolo: Yeah. So the study was positive. The primary endpoint was event-free survival, and it met the primary endpoint. The secondary endpoint of overall survival was also met. So really, really great results. Consistent with what we saw with EV-303, the median event-free survival was not reached for the EV plus pembro arm, and it was 48 months for the patients receiving gem-cis. And then looking at the 24-month estimated event-free survival, it was 79% for the EV plus pembro and 66% for the chemo, the gem-cis arm. And that was a hazard ratio of 0.5. So that is really exciting. That is the event-free survival. And then the overall survival, the medians were not reached for either arm, but when you look at the 24-month estimated overall survival, it was 87% for the EV plus pembro versus 81% for the gem-cis, and that was a hazard ratio of 0.65. So very positive study.  And then another question that we had was the pathologic CR rate. Very consistent with what we saw with the EV-303, the pathologic response rate was about 56% for the patients that received EV plus pembro and about 32%, 33% for the patients that received gem-cis. So very consistent with the findings that we have been kind of seeing in phase 2 studies, and this is a pT0N0, so that is important. Dr. Monty Pal: So Andrea, you know, I think that the big question in folks' minds is at this point, we see the data from NIAGARA, cis-gem-durva, we have now seen this data. Put it into context for us. Is there a patient in this day and age who maybe shouldn't get IO altogether, who should maybe get the NIAGARA regimen as opposed to EV-pembro in this context? What are your thoughts there? Dr. Andrea Apolo: Now, that is a great question. I would say with this data, it is very enticing to give EV pembro to our patients in the perioperative setting, and for that to be the new standard of care for all patients, regardless of cisplatin eligibility. So similar to what we saw with EV-302 really changing the standard of care in the frontline setting, I think these two studies, the EV-303 and the EV-304, change the standard of care for patients with muscle-invasive bladder cancer in the perioperative setting, and this should be the new standard of care if the patients don't have a restriction to receiving an immunotherapy. Dr. Monty Pal: I totally agree with that assessment. It is great to hear it from the expert's mouth as well. Thanks a lot for that, Andrea.  The next abstract I wanted to tackle is one that is, I would say, near and dear to my heart because I know these folks really well. It is led by the SWOG group, and this is SWOG S1602. The number there for the audience gives you a sense of how long the study has been running for. The 16 prefix means it is something that we kicked off back in 2016. So this study is really 10 years in the making, right? So Rob Svatek presented this data. It is interesting, right, because it addresses this issue of the BCG (Bacille Calmette-Guérin) shortage, right, where we have needed to sort of rely potentially on other alternative sources or regimens and so forth. Tell us about this trial, Andrea. Dr. Andrea Apolo: This is one of my favorite studies. We talked about putting it in the main oral abstracts, but we put it in one of the educational sessions that talked about non-muscle-invasive bladder cancer because we thought that would be the best audience for it. But it doesn't take away from how important this abstract is, and the tremendous effort that went into the study. Almost a thousand patients enrolled. I think 984 were eligible to enroll in this study. So it is a very high enrolling, randomized, cooperative group study in high-grade non-muscle-invasive bladder cancer. And really the study was designed to address two questions. One is the BCG shortage and can we use a different strain, Tokyo versus TICE? And whether there is a priming effect if you gave intradermal BCG to patients with non-muscle-invasive bladder cancer, can that enhance the effect if you gave it a little bit earlier? I think the study is really important, and it met its primary endpoint, which was it is not inferior to TICE. The findings were really terrific in terms of the outcomes. Numerically. When you look at the endpoint, it looked like the Tokyo strain was as good, if not maybe a little bit better, but not statistically significant than the TICE. And then they broke it down by carcinoma in situ, they broke it down by papillary tumors, and the Tokyo strain was non-inferior in both of those instances. But interestingly, the intradermal BCG did not change outcomes. There was really no priming effect, which was really backed up by pre-clinical data that there would be, but there wasn't a priming effect when the intradermal BCG was given in the Tokyo strain. So that was a really, really interesting finding. But a great study, really important outcomes in the field for non-muscle-invasive bladder cancer. Dr. Monty Pal: Totally. And it just seems like we can't get away from BCG, right? You know, as hard as we try, I mean, I appreciate the studies that sort of build on it that are emerging right now, but it seems like BCG at least for the foreseeable future is kind of here to stay, right? Dr. Andrea Apolo: It works. It is one of the most effective treatments we have for non-muscle-invasive bladder cancer. So, you know, I think it is here to stay and, you know, we need to find alternatives in terms of strains so we don't deal with this shortage that we have been dealing with for so many years now. Dr. Monty Pal: Yeah, indeed. Moving on to some of the other highlighted studies from the meeting, you had mentioned the EV-303 data, so we probably don't need to rehash that study design in much detail. But there was also a rapid oral abstract presented by Dr. Ullén that I think is of interest here, right, that really hones in on pathologic outcomes and DFS from that trial. Do you mind just outlining that for our listenership? Dr. Andrea Apolo: This is the KEYNOTE-905, also known as the EV-303 study. This is a follow-up to the EV-303 data looking at the pathologic response rates, looking at the downstaging effect, looking at the surgical margins after treatment with the neoadjuvant EV plus pembro in the 303. Now, remember in the 303, patients got three cycles of neoadjuvant EV plus pembro and then six cycles in the adjuvant setting. A little bit different than the 304, where they got four cycles, which is really kind of the standard in the neoadjuvant setting, and then five cycles in the adjuvant setting. So still a total of nine cycles. But in the 303, the treatment arm had no systemic therapy, so it was just radical cystectomy. And they looked at the negative margins that you get with the EV plus pembro treatment, which was 92.6% versus 79% with patients receiving just the surgery alone. And then the pathologic CR rate, there was more follow-up on that, it was 57% for the patients receiving EV plus pembro, and as we would expect, about 9% for the patients that just went on to surgery alone because you can achieve a pathologic response rate with TURBT alone. Then they looked at the pathologic downstaging, so anything less than a pT2, and that was 66% in the patients that received the EV plus pembro. So very interesting findings, and it is also really just nice to have now the EV-304 data, like I was saying, there were two pieces of it, the cisplatin-eligible and the cisplatin-ineligible, and just to have those contemporary controls are really important. How did the cisplatin-ineligible do versus the cisplatin-eligible patient in terms of the event-free survival and in terms of the overall survival? So I feel like now we have all of this data that we can kind of put together in the perioperative setting and we can really inform our patients a little bit more about their outcomes depending on whether they are cisplatin-eligible or not, which you know cisplatin-ineligible patients often just, they are sicker, they may have obstruction, their tumors may be larger, they just tend to be a more delicate population than the cisplatin-eligible patients. So not surprisingly, you know, we see that in the EV-303 the disease-free survival for the patients is pretty poor. So the disease-free survival that was reported for this follow-up of the specific abstract was 23.6 months for the patients that just got surgery, and it was not reached for the patients that had the EV plus pembro, and that was a hazard ratio of 0.37. Dr. Monty Pal: Excellent, excellent distillation. So Andrea, in the interest of time, I mean, we could probably talk about bladder cancer forever, but I am going to move us on to the subject of kidney cancer. We have two late-breaking abstracts, LITESPARK-011, which looked at lenvatinib and belzutifan versus cabozantinib in the advanced setting, and then we have an adjuvant study, LITESPARK-022, that looked at pembrolizumab with or without belzutifan in the adjuvant setting. Both studies positive. One for progression-free survival, the other for disease-free survival. Both I think making a big dent in how we treat kidney cancer. Can you tell us a little bit about that? Dr. Andrea Apolo: Yeah, we have been waiting for these trials for a long time. So one of the things that we have been talking about at GU ASCO is to have plenary sessions. And if we would have had a plenary session, these two abstracts would have been part of it because they are important data, really big studies where we are trying to improve the outcomes of our patients with kidney cancer. So the first one, the LITESPARK-011, like you said, this is for advanced renal cell carcinoma, clear cell renal cell carcinoma, where we really don't have a standard of care after IO therapy, right? So we give IO-IO, we give VEGF-IO, but we don't really have a good standard of care. We usually give monotherapy TKIs. So the combination of belzutifan and lenvatinib versus what a standard of care is, cabozantinib, is really an important question to ask. And you know, this is a pretty large study, about 750 patients were randomized. And belzutifan plus lenvatinib demonstrated an improvement in progression-free survival and overall survival versus cabozantinib, but not overall survival, at least not yet, is what the authors are saying. So for the progression-free survival, the hazard ratio was 0.7 and it was 14.8 months for the combination, belzutifan plus lenvatinib arm versus cabozantinib, which was 10.7 months. So I think that is significant. And for the overall survival, it did favor the combination again with a hazard ratio of 0.85. The median was 35 months versus 28 months for the monotherapy cabozantinib, but it did not reach statistical significance. And the authors said that this will be further tested at a final analysis, these were the interim results.  And for the overall survival, the overall survival was 53% for the combination versus 40%. This is significant. And the CR rates were lowish for both of them, it was like 5% for the combo and 1% for cabo monotherapy. So I think that the findings are important because we don't have a standard of care. And although there is no survival benefit, there was a trend. So I think this could be considered in patients that are fit, a treatment option for these patients in the later line settings. Dr. Monty Pal: Great points. I mean lots of great discussion around toxicity as well as efficacy. I mean certainly this is a regimen that may not be suitable for every patient in my portfolio, but certainly one to consider.  Now Andrea, let's shift focus to LITESPARK-022, the adjuvant trial that I mentioned previously. So this is again looking at pembrolizumab with or without belzutifan, met the primary endpoint of disease-free survival. What are your impressions there of the data? Dr. Andrea Apolo: Yeah, the data looks great. And this was a really large study, 1,800 patients were randomized, and the study met the primary endpoint of disease-free survival, benefiting the combination of pembro plus belzutifan. And that is really terrific. The medians were not reached for either arm. And in terms of the overall survival results, also the medians were not reached, but the hazard ratio was 0.78 and did not reach a statistical significance. So there was again a statistically significant improvement in disease-free survival for the combination of pembrolizumab plus belzutifan, but not an overall survival benefit.  So I guess, Monty, you know, we can kind of talk about what that means. There was a lot of discussion about belzutifan and some of the side effects, specifically anemia and managing anemia in this setting and requirements for transfusions. Generally, the authors said it was well tolerated, but we know that combination studies do have more toxicity. So it may be a select group of patients again, similar to the advanced setting, where we opt for a combination, possibly until we see more follow-up data in terms of the overall survival. Dr. Monty Pal: I have to agree with you. You know, in my group, we have been talking about a lot of pembrolizumab-based studies that are running right now, some through the NCI, some, you know, our own sort of homegrown investigator-sponsored trials, and you know, I think for the foreseeable future we are comfortable just maintaining pembrolizumab. Things might change if, for instance, we ultimately see a survival advantage emerge, but I just have my own personal doubts around that, that will be interesting.  Okay, so now we are going to move to the last disease category that we are going to cover, which is prostate cancer. So there, we have the long-awaited results from the PEACE-3 study. These are the final OS results from this trial looking at enzalutamide with or without radium-223 in metastatic castration-resistant prostate cancer. So Andrea, would love to get your perspectives on this. Dr. Andrea Apolo: Yeah, so this study had been presented before and we had seen positive results for the combination of enzalutamide and radium with some interim overall survival results also showing a benefit. But like you said, these are the final results with a median follow-up of 58 months. So it was really nice to see the final results. And with the combination of enzalutamide and six cycles of radium, it did show an improvement in overall survival with a hazard ratio of 0.76. The median overall survival increased from 32.6 months to 38.2 months with the combination. So that is really great. There was some crossing over of the overall survival curves around 18 months was still seen. And again, there was also an improvement in the rPFS with a hazard ratio of 0.71, and the median rPFS improved from 16.4 to 19 months with the combination. So, you know, we have been awaiting the final results, but we kind of knew a lot about the benefits of the combination. And it is something that is kind of slowly trickling into the community in terms of adapting it and using it. There is more buzz now about it and I think these overall survival results will hopefully shift the community into incorporating the combination in these patients. Dr. Monty Pal: Brilliant. So well said. I mean, Andrea, congratulations on a terrific meeting. You have really done it again. Incredible, incredible output from this year's ASCO GU. I just want to thank you for joining us on the program today. Dr. Andrea Apolo: Oh, thank you so much for having me, Monty. It was really a joy to work with the ASCO team and with all the investigators and the Education Committee and the Scientific Committee. Everyone was really outstanding. So to me it was an honor to be part of this meeting, and I am so happy that it was so successful and really presented some amazing data that I think will be practice-changing to our patients. Dr. Monty Pal: Oh, thanks a ton. And also a huge thanks to our listeners. If you enjoyed the content of today's podcast, please don't forget to like and subscribe to our channel wherever you listen to podcasts. Thanks so much. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:     Dr. Monty Pal   @montypal  Dr. Andrea Apolo @apolo_andrea  Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis     Dr. Andrea Apolo: No disclosures to report.

How solid is your CMC foundation—and what happens if it cracks under pressure?David Brühlmann welcomes Henri Kornmann, former Head of Biologics Innovation Centre at Ferring Pharmaceuticals. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has moved repeatedly between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs.His “house building” approach demystifies CMC's complexity, showing why early diligence paired with regulatory fluency and scientific insight pays dividends for years.Tune in to hear Henri's practical wisdom distilled through real-world analogies:Building a strong CMC foundation in early phases and why later fixes can be costly or impossible (02:45)Scaling up: supplying Phase 3 with the final commercial process, including robustness and supply chain strategies such as dual sourcing critical raw materials (03:23)Process validation explained: FDA's three stages, from control strategy justification to continued verification (05:15)Process Performance Qualification (PPQ): what it is, how many batches are needed, and optimizing timing (07:43)Handling lifecycle changes: maintaining process control, adapting to deviations, and improving systems after regulatory approval (09:34)Managing teams, stakeholders, and cross-functional collaboration in CMC programs (11:49)Importance of good project management, access to scientific expertise, and interpreting guidelines for your specific program (12:27)The “half scientist, half lawyer” analogy for mastering both technical and regulatory aspects (15:08)Smart insight:Never underestimate CMC. If you do, you will pay for it later.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Host: Sabiha Gati Guest: Thomas F. Luescher Want to watch that extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2556 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode.  The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology this Week: A concise summary of recent studies The future of guidelines in an era of big data and AI Exercise in hypertrophic cardiomyopathy Snapshots Host: Sabiha Gati Guests: Kostas Koskinas, Thomas F. Luescher, Michael Papadakis, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2556 Want to watch the extended interview on The future of guidelines in an era of Big Data and AI, go to: https://esc365.escardio.org/event/2556?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode.  The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Sabiha Gati, Nicolle Kraenkel and Thomas F. Luescher have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada.  Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of compelling stories that highlight the intricate interplay of scientific innovation, regulatory dynamics, and strategic maneuvers shaping the industry.Starting with Moderna, the company has reached a pivotal resolution in a long-standing patent dispute involving its mRNA-based COVID-19 vaccine, Spikevax. This settlement involves a hefty $950 million payout to Genevant Sciences and Arbutus Biopharma, resolving claims of patent infringements. This agreement underscores the complex nature of intellectual property in the rapidly evolving mRNA landscape. Securing patent rights is crucial as new vaccines and therapies are developed, and this resolution not only clears a legal hurdle for Moderna but also exemplifies the industry trend towards resolving such disputes to foster continuous innovation.Sanofi has embarked on a significant strategic move by entering a $1.53 billion global licensing deal with Sino Biopharmaceutical. This agreement secures rights to a first-in-class JAK/ROCK inhibitor, which shows promise in treating hematological and immunological conditions. Such collaborations reflect the increasing focus on innovative therapies that target complex biological pathways, highlighting how companies are seeking unique assets to bolster their competitive edge.Regulatory scrutiny continues to be a formidable theme in the industry. The FDA has intensified its oversight on compounded GLP-1 drugs, issuing 30 warning letters to telehealth companies marketing unauthorized versions. This action highlights the agency's commitment to ensuring drug safety and efficacy while emphasizing the challenges companies face in navigating regulatory landscapes for compounded medications. Additionally, Novo Nordisk has been cautioned by the FDA regarding advertising practices for GLP-1 receptor agonists, illustrating the ongoing regulatory focus on pharmaceutical marketing strategies and compliance standards.Meanwhile, Bayer is experiencing a period of resilience in its pharmaceutical division, driven largely by its cancer drug Nubeqa and cardiovascular agent Kerendia. Despite these successes, Bayer faces challenges as revenues from older drugs like Xarelto and Eylea decline. This scenario reflects a broader industry challenge where companies must innovate while managing mature product lines facing generic competition.Teva Pharmaceuticals is making strategic strides by securing a $400 million deal with Blackstone to develop an anti-TL1A antibody for inflammatory bowel disease (IBD), in partnership with Sanofi. This investment highlights continued interest in autoimmune and inflammatory conditions as lucrative targets for novel therapies. Financial partnerships like Teva's substantial agreement with Blackstone illustrate how such collaborations can support sustained R&D efforts in chronic disease management.Technological integration into healthcare is expanding rapidly, with Nvidia collaborating with Droplet Biosciences to explore AI applications in medtech and cancer research. These partnerships illustrate an industry shift towards leveraging artificial intelligence to enhance diagnostic capabilities and accelerate research efforts. Moreover, collaborations leveraging AI/ML technologies across drug discovery pipelines are gaining traction; Earendil Labs partnering with WuXi XDC exemplifies this trend alongside Merck & Co.'s multi-year AI oncology data deal with Tempus—enhancing precision medicine capabilities while expediting therapeutic discoveries.In terms of funding new therapeutic areas, ARPA-H has announced a $158 million initiative aimed at developing medicines targeting the lymphatic system. This marks an exploration into less charted territories within physiological research that could yield transforSupport the show

• US equity markets fell sharply as oil prices resumed their march higher after Iran claimed to have attacked a tanker in the Strait of Hormuz - Dow fell -785-points or -1.61%, having been down over >1,100 points or ~2.4% earlier in the session. Caterpillar Inc (-3.54%), Goldman Sachs Group Inc (-3.67%), Merck & Co (-3.5%), Sherwin-Williams Co (3.51%) and Walmart Inc (-3.52%) all fell 3.5%+. Salesforce Inc rallied +4.3% to be the leading performer in the 30-stock index as software stocks more broadly continued to rebound. Nvidia Corp edged +0.16% higher, recovering from an earlier decline that came Bloomberg News reported that the U.S. government is looking to add major restrictions to artificial intelligence (AI) chip exports. According to the report, U.S. officials have proposed regulations that would require U.S. companies to seek permission for all exports of AI accelerators, expanding restrictions that currently cover around 40 countries. The U.S. would only approve massive exports - such as more than 200,000 Nvidia GPUs owned by a single company - to allies that make strict security promises and “matching” investments in American AI, Bloomberg reported, citing sources. However, the proposal is not finalised and could see substantial changes.

APAC stocks extended on losses with markets roiled by the widening conflict in the Middle East; KOSPI saw a double-digit percentage drop and had triggered a circuit breaker with declines led by shipbuilders and shipping firms.Iran hit more than 10 tankers that ignored warnings and warns ships against transiting the Strait of Hormuz, according to FARS.US President Trump said, "If necessary, the United States Navy will begin escorting tankers through the Strait of Hormuz, as soon as possible".US President Trump announced with immediate effect that the US is to provide political risk insurance and guarantees (at a very reasonable price) for the financial security of all maritime trade, especially energy, travelling through the Gulf.European equity futures indicate a slightly lower cash market open with Euro Stoxx 50 futures down 0.4% after the cash market closed with losses of 3.6% on Tuesday.Looking ahead, highlights include Swiss CPI (Feb), Global Final Composite/Services PMIs (Feb), EZ Unemployment (Jan), PPI (Jan), US ISM Services PMI (Feb), NBP Policy Announcement. Speakers include ECB's Cipollone, de Guindos & BoC's Macklem. Supply from Germany, Earnings from Broadcom, Merck & Deutsche Post.Read the full report covering Equities, Forex, Fixed Income, Commodites and more on Newsquawk

The FDA is dominating the headlines once again thisweek.  Days after FDA Commissioner Marty Makary appeared to question uniQure's gene therapy candidate for Huntington's disease, the company revealed that the agency will require it to conduct a randomized, double-blind, sham surgery–controlled Phase 3 study. The FDA also published anothercomplete response letter (CRL), this one for REGENXBIO's gene therapy for Hunter syndrome. The rejection, sustained by the biotech early last month, was driven by issues with the study's population, controls and use of surrogate markers to measure efficacy, according to the document.  Meanwhile, regulatory experts have expressed concernsthat the FDA's circle of trust is shrinking, making many decisions feel like “fiat”—both in terms of individual drug applications and policy. The FDA has reportedly initiated a probe into complaints that a toxic workplace is fostered by CBER director Vinay Prasad, who is at the heart of many of these decisions. Finally, the biopharma industry continues to react to the agency's pivot from a requirement of two pivotal trials to one for approval, asking why now, what are the risks and what exactly the FDA expects from this one trial.   Still on the gene therapy front, Sarepta Therapeutics CEO Doug Ingram stepped down last week to spend more time with family as the company's muscular dystrophy mission hits home. Also during the company's fourth quarter earnings call, Sarepta projected that sales of its embattled Duchenne muscular dystrophy gene therapy Elevidys will be flat or down as far as 15% in 2026.  On the obesity front, Eli Lilly topped Novo Nordisk again in a weight loss trial, this time in a Lilly-sponsored study of patients with type 2 diabetes. But don't count Novo out yet. The company is actively seeking out new obesity assets, according to business development executive Tamara Darsow. Just last week, Novo linked with Boston'sVivtex to advance novel weight loss pills.Finally, check out BioPham Executive this week for a rundown of 2025's top-selling assets—spoiler: Merck's Keytruda held onto its crown as number one—and a story on former2seventy exec Chip Baird's new role as CEO of recently launched Poplar Therapeutics, which secured a $45 million series A extension this week.

Heute freuen wir uns wieder einen Gast bei uns im Shanghai Office begrüßen zu dürfen. Marc Horn blickt auf eine lange Zeit in China zurück und war seit 2001 insgesamt dreimal für Merck in China im Einsatz. Da er zum 1. März eine neue Rolle in Deutschland antritt, ist dieser Besuch bei uns im Studio ein Teil seiner Abschiedstour. Wir sprechen über den Wandel vom reinen Importeur zum lokalen Business und warum es heute nicht mehr reicht, nur eine Präsenz in China zu haben. Marc erklärt, dass Unternehmen ein echter Teil des chinesischen Marktes werden müssen, um bei der Geschwindigkeit in Bereichen wie KI oder Robotik überhaupt mithalten zu können.Spannend ist auch sein Blick auf die lokale Konkurrenz, die bei Kosten und Qualität massiv aufgeholt hat. Marc beschreibt, wie diese Firmen für Merck gleichzeitig zu wichtigen Kunden und Partnern geworden sind. Er betont, dass für diesen Erfolg nicht nur Expertise vor Ort, sondern vor allem auch China-Kompetenz im globalen Headquarter entscheidend ist.Außerdem sprechen wir über den Ausbau von Green Energy und die Anwendung von KI-Modellen wie DeepSeek im Arbeitsalltag.Wir wünschen Marc alles Gute für seinen Neustart in Deutschland und euch viel Spaß mit dieser Folge.Unser Gast: Marc HornSend a textasiabits hier abonnieren: asiabits.com Damians Team kontaktieren: www.genuine-asia.com Moderatoren & Hosts: Damian Maib & Thomas Derksen Schnitt & Produktion: Eva Trotno

Seventy percent of FDA Complete Response Letters have a CMC root cause. Most of those failures trace back to decisions made years earlier. Decisions that felt minor at the time and proved impossible to fix later.Henri Kornmann has spent two decades making those decisions the right way. From junior CMC scientist at Merck to leading Ferring Pharmaceuticals' first gene therapy approval for bladder cancer, Henri has crossed between CMC development, GMP manufacturing, and due diligence across some of the industry's most complex programs. His conclusion: a CMC program is like building a house. Get the foundation wrong and no amount of late-stage effort will save you.In Part 1, Henri reveals the decisions that cannot be undone and how to get them right from the start.What you will learn:Evolution of cell bank technology and regulatory expectations (00:33)The impact of weak CMC foundations on late-stage failure (00:51)Lessons learned from Ferring's gene therapy approval and CMC gap analysis (06:51)FDA statistics on CMC issues in INDs and response letters (08:07)Critical early decisions: cell bank clonality and proper storage practices (10:22)The importance of comprehensive raw material documentation (12:29)Early analytical characterization and discovering molecular “funkiness” before phase trials (13:41)Supply strategy for phase 2—why stability and batch knowledge matter (14:49)Introduction to critical quality attributes (CQA), process parameters, and quality-by-design principles (15:52)Common pitfalls in CQA identification and continued process verification (17:01)Smart insight:The therapies that reach patients aren't built on heroic late-stage rescues. They're built on disciplined early decisions: the right cell bank, the right analytics, the right documentation. Henri's message is unambiguous: there are CMC mistakes you can fix later, and there are CMC mistakes you cannot. Knowing the difference is the foundation of every successful biologics program.In Part 2, Henri walks through scale-up to commercial manufacturing, process validation stages 1 through 3, post-approval control strategy, and the project management and regulatory fluency that separate successful CMC leaders from the rest.If this topic resonates with you, here are a few related episodes where we dive deeper into building strong CMC foundations and avoiding costly development mistakes:Episodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerConnect with Henri Kornmann:LinkedIn: www.linkedin.com/in/henri-kornmann-9b6869Next step:Need fast CMC guidance? → Get rapid CMC decision support hereSupport the show

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into a series of significant advancements and ongoing challenges that are reshaping the landscape of these dynamic industries.A key highlight in recent developments comes from Ascendis Pharma, which has secured FDA approval for Yuviwel, a treatment targeting achondroplasia, a genetic disorder leading to dwarfism. This approval underscores the potential of Ascendis' "transient conjugation" drug delivery platform, marking its third rare disease drug approval in just six years. The platform's ability to extend drug half-life and improve dosing frequency highlights its promise in addressing unmet medical needs in rare diseases, offering new hope for patients who previously had limited treatment options.In oncology, Merck's LITESPARC clinical trial program is showing promising results with Welireg (belzutifan) for clear cell renal cell carcinoma. The trials suggest that combination therapies involving Welireg could set a new standard of care. However, transitioning these regimens into universal standards remains challenging due to competitive dynamics and hurdles in clinical adoption.Shifting to cardiovascular health, United Therapeutics has made notable progress with its phase 3 trial success for a once-daily drug candidate for pulmonary arterial hypertension. The trial reported a 55% reduction in clinical worsening risk, positioning United Therapeutics to seek FDA approval and potentially challenge existing treatments from major players like Johnson & Johnson.Regulatory challenges are also evident. UniQure recently faced a setback when the FDA rejected its data package for AMT-130, a gene therapy for Huntington's disease. This rejection reflects the stringent regulatory environment surrounding gene therapies and emphasizes the need for robust data to meet approval criteria.On the technological front, Eli Lilly is making a strategic shift by collaborating with Nvidia to integrate advanced computing capabilities into drug development. By leveraging Nvidia's AI-driven supercomputing power, Lilly aims to accelerate drug discovery processes and enhance precision medicine approaches, potentially transforming traditional pharmaceutical lifecycles.Operational shifts are also occurring as Merck winds down Gardasil production at its North Carolina plant due to declining global demand. This decision reflects broader vaccination trends and may signal shifts in manufacturing strategies to align more closely with market demands.Leadership changes at Bavarian Nordic, following a failed private equity takeover bid, indicate potential strategic realignments within the company. The planned departure of CEO Paul Chaplin after 12 years could herald new directions and priorities.In logistics, Frontier Scientific Solutions is pioneering advancements in temperature-controlled supply chains—crucial for maintaining drug efficacy during distribution. Their innovative approaches are reshaping pharmaceutical logistics, ensuring reliable delivery systems worldwide.Meanwhile, Walgreens is venturing into digital health with a virtual weight management clinic offering access to GLP-1 medications. This move positions Walgreens within the competitive telehealth market as it responds to growing consumer demand for convenient healthcare solutions.These developments collectively reflect an industry in flux—balancing scientific innovation with regulatory rigor and strategic realignments. As companies navigate these challenges, the implications for patient care are profound, promising potential improvements in treatment efficacy and accessibility.Turning our attention to Roche, another successful Phase 3 trial for fenebrutinib—a BTK inhibitor targeting relapsing multiple sclerosis—has been reported. The study achieved its primary endpoint but raiseSupport the show

You know them by their trade names such as Ozempic, Wegovy, Mounjaro, and Zepbound. This class of medications is known as GLP-1 receptor agonists. And while they are best known for managing diabetes and promoting weight loss, researchers are finding that these drugs are also effective in a broad range of other health conditions. So, what about MS? My guest this week is Dr. Ellen Mowry, the principal investigator of a clinical trial to determine whether a GLP-1 drug can reduce brain inflammation and provide neuroprotection in people living with progressive MS. We're sharing details about the discovery of a new biomarker that not only confirms an MS diagnosis but also predicts the severity of an individual's disease course in the years ahead. We'll tell you about three studies focused on better managing some of the most common MS symptoms and funded by the International Progressive MS Alliance. And we'll explain how Merck and the Mayo Clinic are partnering to build a first-of-its-kind drug discovery platform using AI. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: A GLP-1 for MS?  :22 I'm asking for your support:  1:31 Researchers discover biomarkers that can predict future disease course  2:13 The International Progressive MS Alliance invests $8.1 million in global studies that address the most common MS symptoms   5:44 Merck and the Mayo Clinic collaborate on AI-driven drug discovery platform  10:02 Dr. Ellen Mowry discusses the clinical trial to determine whether a GLP-1 drug can reduce inflammation in the central nervous system and offer neuroprotection to people with progressive MS  12:20 Share this episode  30:17 Next week  30:38 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/444 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com Support Jon at WALK MS https://realtalkms.com/walkms STUDY: Large-Scale Proteomics Across Neurological Disorders Uncovers Biomarker Panel and Targets in Multiple Sclerosis https://pubmed.ncbi.nlm.nih.gov/41747728 International Progressive MS Alliance https://progressivemsalliance.org JOIN: The RealTalk MS Facebook Group https://facebook.com/groups/realtalkms REVIEW: Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 444 Guests: Dr. Ellen Mowry Privacy Policy

Are you holding yourself back from biotech roles because you don't check every box on the job description? You're not alone, and it's costing you opportunities.In this career chat, Carina sits down with Heer Shah, a Scientist in cell and gene therapy at Ensoma, a Boston-based biotech developing precision gene therapies using synthetic viral vectors and gene editing technologies. Heer has over seven years of biotech experience spanning vaccines, AAV, lentiviral vectors, VLPs, and LNPs, with roles at Merck, Intellia Therapeutics, Ring Therapeutics, and Sana Biotechnology. Heer holds a Master's in Biotechnology from Northeastern University, where the co-op program launched a career built on hands-on industry experience from day one. Today, Heer does vector engineering and gene editing optimization for programs targeting sickle cell disease and immuno-oncology.Heer shares how foundational lab skills and a big-picture mindset opened doors at every stage, and what it really takes to build a long-term biotech career across multiple modalities.Key takeaways from this episode:Why job descriptions are wish lists, not checklists, and why hiring managers value learning ability over a perfect resume matchHow to position diverse experience across biotech modalities as a competitive advantageThe difference between specialists and integrators, and why companies need bothWhat it's like surviving multiple rounds of biotech layoffs and how to build career resilienceHow the Northeastern co-op program helped Heer explore different company sizes and career paths before committingWhy behavioral interview questions often matter more than technical onesHow international scientists can navigate visa pathways, including the National Interest WaiverThe career advice Heer wishes someone gave earlier: tell your story soonerWhether you're early in your biotech journey or navigating a career transition, this conversation is packed with practical advice on building transferable skills, staying adaptable, and landing roles you're excited about.Want scripts, practice drills, and feedback from peers in biotech?Join our Biotech Career Coach Skool community: https://www.skool.com/biotech-career-coach/aboutConnect with Heer on LinkedInLearn more about the Collaboratory Career Hub community and access our free resources:Join our Skool CommunityTake the Free 7-day Interview Sprint ChallengeCheck out our sister podcast: Building BiotechsSend Carina a connection request on LinkedIn!Stay connected with us:

In dieser Folge begrüßt Markus Reitshammer einen Experten an der Schnittstelle von Naturwissenschaft und Digitalisierung: Jan Gerit Brandenburg. Er leitet die Abteilung für digitale Chemie bei Merck, einem Unternehmen mit einer beeindruckenden 350-jährigen Geschichte. Das Gespräch gibt einen tiefen Einblick in ein Feld, das die Art und Weise, wie wir Medikamente entwickeln und Hochleistungsmaterialien entdecken, grundlegend verändert. Weg vom reinen „Trial and Error“ im Labor, hin zu präzisen Vorhersagen am Computer.

Guest: Martin Brenner, Ph.D., Chief Executive Officer and Chief Scientific Officer at iBioCompany: iBio, Inc. (NASDAQ:IBIO)Website: https://ibioinc.com/Martin's Bio:Dr. Brenner has a strong history of success heading drug discovery and development teams at several of the world's leading pharmaceutical companies, including AstraZeneca, Eli Lilly and Company, Pfizer Inc., and Merck Research Laboratories. Most recently, Dr. Brenner served as the CSO at Pfenex Inc., which, using its patented Pfēnex Expression Technology® platform, created an advanced pipeline of therapeutic equivalents, vaccines, biologics and biosimilars. Pfenex was acquired by Ligand Pharmaceuticals Incorporated for approximately $516 million in October 2020. Previously, Dr. Brenner served as the CSO at Recursion Pharmaceuticals, Inc., a company focused on accelerating drug discovery for rare diseases and diseases with high unmet medical need. Prior to his time at Recursion, he was Vice President and Head of Research & Early Development at Stoke Therapeutics, Inc., a biotechnology company using antisense oligonucleotides to increase gene expression for the treatment of rare diseases. Prior to Stoke, he was Executive Director at Merck, where he built a biotech unit from scratch, focusing his team's research on diabetes and nonalcoholic steatohepatitis (NASH). Earlier in his career, Dr. Brenner was the Senior Director and Head of cardiovascular, renal, and metabolism (CVRM) biosciences at AstraZeneca. In addition, Dr. Brenner was an Associate Research Fellow at Pfizer where he led the islet biology and in vivo pharmacology in the CVMED Target Exploration Unit before assuming the role of Head of the Insulin Resistance Group.Company Description: iBio is a cutting-edge biotech company leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic diseases, obesity, cancer and other hard-to-treat diseases. By combining proprietary 3D modeling with innovative drug discovery platforms, iBio is creating a pipeline of breakthrough antibody treatments to address significant unmet medical needs. iBio's mission is to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine.

Gregory Zuckerman details Gail Smith's insect-based vaccine technology at Novavax and discusses how major pharmaceutical giants like Merck initially hesitated to join the pandemic race. 4

The I Love CVille Show headlines: Henley Middle School ICE Truancy Student Protest Today Are We Accepting 12 Year Olds Skipping School? Elementary School Students Next Age Group To Protest? AlbCo Supe Pruitt Says Funding Not There For 4th HS VA Judge Blocks Democrats' Gerrymandering Efforts UVA BOV Names Dominion Energy Boss As Rector Eli Lilly, AstraZeneca, Merck: $12.5B + 1,750 New Jobs In Area The Most Important 3 Minutes Of News Today (2/20/26) Read Viewer & Listener Comments Live On-Air The I Love CVille Show airs live Monday – Friday from 12:30 pm – 1:30 pm on The I Love CVille Network. Watch and listen to The I Love CVille Show on Facebook, Instagram, Twitter, LinkedIn, iTunes, Apple Podcast, YouTube, Spotify, Fountain, Amazon Music, Audible, Rumble and iLoveCVille.com.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a series of transformative events reshaping the industry landscape, from scientific breakthroughs to regulatory shifts and strategic corporate maneuvers.Let's start with Insmed's Brinsupri, a newly approved respiratory therapy that has captured attention with its projected $1 billion in sales by 2026. This ambitious forecast is grounded in Brinsupri's robust clinical efficacy and the increasing demand for innovative respiratory treatments. This development reflects a broader industry trend where targeted therapies are not only improving patient outcomes but also driving significant revenue growth. As respiratory conditions continue to be a major health challenge globally, the success of therapies like Brinsupri underscores the potential for innovation to meet these critical needs.In parallel, Merck is working strategically with its RSV antibody, Enflonsia, seeking a second-season approval to bolster its competitive stance against Sanofi and AstraZeneca's Beyfortus. The race in infant RSV prevention is intense as companies vie to establish dominance in this crucial segment of infectious disease management. Merck's efforts highlight the broader push within the industry to develop preventive measures that could significantly alter public health landscapes by reducing the incidence of severe respiratory illnesses in vulnerable populations.Meanwhile, regulatory scrutiny remains a constant for pharmaceutical companies. The FDA's recent review of Johnson & Johnson's advertising for Tremfya, targeting ulcerative colitis, emphasizes the agency's commitment to ensuring that efficacy claims are both truthful and transparent. This serves as a reminder of the importance of maintaining regulatory compliance and ethical advertising practices within the industry—a critical aspect as companies navigate complex marketing landscapes while ensuring patient trust.Shifts in leadership within key health organizations are also noteworthy. Jay Bhattacharya stepping into the role of acting CDC chief after Jim O'Neill's departure could signal changes in public health policy and research priorities. Such transitions can have profound effects on how emerging health challenges are addressed, potentially influencing everything from vaccine distribution strategies to research funding allocations.As we turn to policy discussions, President Donald Trump's most favored nation drug pricing proposal continues to stir debate. This initiative aims to lower drug prices by benchmarking them against international rates, but it faces resistance from free-market advocates who argue it could stifle pharmaceutical innovation. The ongoing discussion around drug pricing reform is pivotal, as it impacts both patient access to medications and the incentives for companies to invest in new drug development.Strategic realignments in the contract development and manufacturing organization (CDMO) sector are also making headlines. Recipharm's sale of its Israeli API plant to Scinai Immunotherapeutics, alongside a new CDMO partnership, illustrates how companies are optimizing resources to focus on core competencies and expand service offerings. This strategic shift highlights the dynamic nature of CDMOs as they adapt to changing market demands and technological advancements.In Alzheimer's research, there's promising news with a study suggesting that a blood test could predict when symptoms will appear, representing a significant leap forward in early diagnosis and intervention strategies. These advancements offer hope for altering the treatment landscape of neurodegenerative diseases through timely therapeutic interventions that could improve quality of life for patients. However, challenges remain as seen with Johnson & Johnson pausing enrollment in itsSupport the show

Dr. Monty Pal and Dr. Ari Rosenberg discuss the evolution of treatment strategies in head and neck cancers, including the challenges of treating both HPV-positive and HPV-negative disease and the emergence of blood-based biomarkers to advance personalized therapy across different subtypes. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center in Los Angeles. Today, we're going to explore the evolving landscape of treatment strategies in head and neck cancer management, including locoregionally advanced head and neck squamous cell carcinoma, which happens to be on the rise in United States, in part due to spike in HPV-mediated oropharyngeal cancers. We're also going to discuss the emerging strategies of using blood-based biomarkers to really advance personalized therapy. Joining me for this discussion is Dr. Ari Rosenberg. He's a medical oncologist focused on head and neck cancer, and he's an associate professor – congratulations on the recent promotion – at the University of Chicago. The University of Chicago has really produced luminaries in this field, Dr. Rosenberg included. I've had the pleasure of getting to know Dr. Ezra Cohen over the years, who really had his grounding there, and of course Everett Vokes, former ASCO President. I'm really looking forward to this conversation, Ari. Thanks so much for joining us. Dr. Ari Rosenberg: Thanks, Monty. Thanks for the invitation. Dr. Monty Pal: You got it. And just a quick note for our listeners, our full disclosures are going to be in the transcript at the end of this episode. So let's start with the basics, if you don't mind. So, head and neck cancers are very diverse and they're challenging, right? In the sense that they're near vital organs, the treatments, you know, as we all saw during fellowship, if not now in clinical practice. They can really have such a major impact on vital organ function, speech, swallowing, et cetera. Can you just comment on head and neck cancers that are on the rise in the U.S.? I alluded to this briefly. Particularly, we've heard this in the context of colorectal cancer and so forth. Are you actually seeing younger adults being affected by this? Dr. Ari Rosenberg: Yeah, thanks for that. The vast majority of head and neck cancers are head and neck squamous cell carcinomas, as I'm sure many of the listeners recall as well from fellowship or their current training. And as you alluded to, the organ function, long-term and functional quality of life outcomes are quite important, particularly in the context that these develop in high value real estate, parts of our head and neck area that we use for speaking, swallowing, all sorts of other essential functions as well. As you also alluded to, we think of this in two different particular subtypes of head and neck cancer. The historical head and neck cancer from 50, 60 years ago was almost exclusively related to carcinogen exposure, tobacco, alcohol use, and that subtype of carcinogen-induced head and neck cancer has been slowly declining. However, over the last now several decades, we've been seeing an increase in primary oropharyngeal squamous cell carcinoma, mostly tonsil, base of tongue. These are attributable to HPV, human papillomavirus exposure. And that's now the majority of the head and neck cancers that we tend to see in our clinic. As you also alluded to, these have very different prognoses as well. HPV-related head and neck cancer has a much more favorable prognosis where much of the interest has been in can we de-intensify to optimize long-term function? But then the non-HPV-related head and neck cancer, or what we call HPV-negative head and neck cancer, continue to be very, very challenging. We only managed to cure about half of these folks, with many of these patients developing the current disease. These patients, in addition to being difficult to treat, also have major impacts both in terms of the treatments they undergo as well as their disease that can impact their function and quality of life. And you hinted at this a little bit, but we have been seeing an increase in younger patients with HPV-negative head and neck cancer as well, which is quite concerning. Younger patients, oftentimes never smokers, never drinkers, who are developing non-HPV-negative head and neck cancer. And that's been a little bit of a more recent trend that we've been seeing as well. So, definitely a lot of work to be done to optimize and improve outcomes across all of these different head and neck cancer subtypes. Dr. Monty Pal: I mean, I'm just curious, you know, in the context of colorectal cancer, one of the things that we talk about is the potential role of the microbiome driving some of these young-onset cancers with, you know, perhaps there being an impact on, for instance, inflammation and the gut and what have you. Tell me about head and neck cancer. Is this anything known as to why younger patients might be getting diagnosed with non-HPV type cancers? It's odd to me. Dr. Ari Rosenberg: Yeah, it's a great question. A lot of people are working on it. I think we folks have hypotheses, but it hasn't totally panned out exactly what's going on there. It does have a little bit more of a tendency towards women, whereas historically head and neck cancer is much more common in men than it is in women. But lots of people working on that, whether it's related to chronic inflammation, whether it's related to the microbiome. Whether it's related to dental exposure, dental work. So, a lot of folks trying to parse that out because I agree with you, it needs to be identified alongside improving treatment paradigms for these patients, the young ones and the older patients as well. Dr. Monty Pal: Interesting, interesting. You know, one of the phenomena that was sort of coming around when I was in training 25 years ago was this role of sort of induction therapy for head and neck cancers. And of course, it's really come full circle now to include checkpoint inhibitors and so forth. Tell me a little bit about this and how you apply it, maybe in an HPV-mediated context, maybe in a non-HPV context. Dr. Ari Rosenberg: Yeah, absolutely. Induction chemotherapy, as you alluded to, or neoadjuvant chemotherapy, depending on what the locoregional treatment approach is. Similar to other cancer types where systemic control early on has many potential advantages in this setting. Now, in head and neck cancer, even though induction chemotherapy is quite active in head and neck cancer, both HPV-positive and HPV-negative with pretty good response rates. A survival advantage for all comers with local regionally advanced disease remains unproven. There's been two randomized trials, both underpowered, but essentially did not show a survival advantage, showing that induction chemotherapy for all patients with locoregionally advanced and neck cancer can't be justified for a survival advantage. That being said though, there remains a number of potential advantages of giving induction or neoadjuvant chemotherapy, of course, improving systemic control and debulking the disease early on has potential advantages, and predicting the responsiveness to subsequent radiation treatment. We know for some time in head and neck cancer that the percentage of shrinkage or the response to induction chemotherapy actually predicts outcome related to radiation as a dynamic biomarker where response can be used to select patients, for example, for de-escalated radiation has been an area of active investigation, active research. And it also remains a key opportunity to evaluate predictive biomarkers and understanding pre and post treatment to better understand the biology. I'll just add to your question that recently over this past year, we also saw phase 3 data for neoadjuvant immunotherapy for a subset of head and neck cancer that is surgically resectable. And so that's reintroducing the potential benefit in the immunotherapy era of incorporating immunotherapy in the neoadjuvant or the induction setting as part of the evolving treatment paradigm for these diseases. Dr. Monty Pal: That's really interesting. And you kind of alluded to already several topics that I plan to hit on, you know, for instance, the role of immune checkpoint inhibitors, induction, chemotherapy, and so forth. And you started to touch on biomarkers. And of course, I think that's something near and dear to many of us in academic oncology. One thing that we've started talking a lot about in the context of colorectal cancer is circulating tumor DNA. How do you think this might fit in the context of head and neck cancer? Can you give us a flavor for that? Dr. Ari Rosenberg: Yeah, absolutely. In head and neck cancer, the current landscape is most developed for circulating tumor DNA for HPV-related head and neck cancer. The advantage of HPV-related head neck cancer is that you have a distinctive HPV DNA that does tend to spill out into the peripheral blood and can be detected using various different blood-based assays. And because of that advantage as a tissue agnostic approach, it turns out that a number of HPV DNA plasma assays are actually quite sensitive and quite specific. And a number of them have indeed been commercialized. Of course, not only for detecting a baseline, but also grading responsiveness during treatment and probably most importantly in the post-treatment surveillance setting, the detection of HPV DNA in the plasma remains a very important and substantial predictor of developing recurrent disease. There's been a number of trials that have been emerging looking at ctDNA and HPV-related head and neck cancer, using it, for example, as a strategy to deescalate patients. That was something we saw this past ASCO from the Dana-Farber group, and also using it to early detect recurrence and potentially intervene earlier for patients with minimal residual disease positivity. So, that remains evolving and as many folks are, I think, already using it in the clinic. But ctDNA also has a lot of potential for HPV-negative head and neck cancer. This is actually a bit more challenging to develop because you don't have that HPV DNA that you can track predictably because the tumor is an HPV- negative disease are much more heterogeneous, but there are a number of data that are coming out both for personalized assays such as Signatera or some of the other assays that require tumor. Unlike colon cancer, which you referenced, where most patients get surgery upfront, in head and neck cancer, many of the patients receive non-surgical pre-chemoradiation. So sometimes the amount of tumor available to generate a personalized assay is more limited and can be one of the challenges that we see in head neck cancer. But certainly that also seems to be emerging. And there's also further assays that are being developed for HPV-negative head neck cancers, such as methylomic signatures and others that may be tissue informed or tissue agnostic. And these are also emerging, particularly in the post-treatment surveillance setting as strong predictors of recurrent disease. So while we're certainly behind some of these other more common tumor types, colon cancer, lung cancer, we're right there with them and more and more trials are going report out, including a number of trials in our upcoming [University of Chicago] Head and Neck Cancer Symposium where I'll be presenting some data and others in the field will be presenting some data looking at ctDNA both for HPV-positive and for HPV- negative to try to improve outcomes for these patients. Dr. Monty Pal: That's so interesting. I've got to tell you that in kidney cancer, what I deal with day to day is a very low shedding disease, right? So techniques as opposed to ctDNA looking for tumor-informed information, that might be less preferred to something like methylomics where you might not necessarily be so contingent on what's happening in the primary tumor. I'm really interested in you mentioning that. Just a point of clarification, this is something I'm trying to wrap my head around. You'd mentioned circulating tumor HPV DNA, right? I assume this is markedly different from just looking for HPV titers in the patient, right? So is this actually incorporated elements of HPV within, you know, essentially host genome, if you will? Dr. Ari Rosenberg: Yeah, correct. This is circulating tumor HPV DNA. And we think of it biologically as a plasma-based tumor DNA biomarker that's specific for HPV-related head and neck cancers. Dr. Monty Pal: Got it, got it. It makes me wonder whether or not this might be applicable to diseases like cervical cancer and so forth where there's also extensively, you know, biology driven by HPV. Is that fair? Dr. Ari Rosenberg: Yes, definitely. And in the head and neck cancer field, much of this ctDNA actually was derived from a different viral mediated head neck cancer, is less common in the U.S., but nasopharyngeal cancer, which is oftentimes associated with EBV. That has been a biomarker for quite some time in nasopharyngeal cancer. Of course, in places where EBV-associated nasopharyngeal cancer, is endemic, such as East Asia, this has been around for quite some time, but we've been using that in the U.S., and there's been trials that have used EBV DNA plasma to predict recurrence and stratify for adjuvant treatment, for example. And so now with HPV, it's much more applicable to our US population because the vast majority of our head and neck cancer patients that we see in the US that are viral mediated in the US tend to be HPV-related. So having assays that we can use to improve outcomes for that biological subset remains of particular interest for us. Dr. Monty Pal: Yeah, that's fascinating. By the way, for the fellows listening, there's tons of boards pearls here that Dr. Rosenberg shared, EBV-associated cancers, the role of HPV and treatment association. So if you're recertifying anytime soon, I definitely think there's notes to take from this conversation indeed. I wanted to shift gears a little bit. And obviously, you're a prolific researcher. I don't think anyone goes through their fellowship in medical oncology without recounting these experiences of our head and neck patients really suffering from treatment-related toxicities. It's a real challenge. And I'm just wondering, I know a big body of work that you're focused on is really using multimodality treatment paradigms to perhaps reduce the cumulative treatment burden of patients with head and neck cancers. Can you talk about that a little bit? Dr. Ari Rosenberg: Yeah, definitely. Thanks for the question. And before I start going into some of the strategies, I'll just say that head and neck cancer, this is particularly for the fellows that are listening as well, just in reference to your prior comment, that this is really a multidisciplinary disease. At our center, all head and neck cancer patients are seen upfront at that first visit by all three specialties, med onc, rad onc, and surgery, because the choice and sequencing of modalities to optimize not only survival, but also functional quality of life outcome is so critical. And I think that's probably the biggest takeaway for anyone who treats a lot of head and neck cancer or will be treating a lot of head and neck cancer in the clinic. But in terms of more specific attempts at trying to optimize some of those parameters that you described, we really think about these separately in terms of HPV-positive and HPV-negative head and neck cancer. For HPV-positive head and neck cancer, the cure rates are quite high with chemo radiation, although not for everyone. There's still about 15, 10 to 15 % of folks that will develop a recurrence. But for the vast majority of patients, standard chemoradiation is quite a cure to therapy, but the toxicity associated with that can be quite substantial. And so there's been a number of attempts to try to deescalate treatment. It turns out that deescalating everyone with locoregionally advanced HPV-positive head and neck cancer is not a good strategy because it's not able to select out the patients that really do need full dose treatment. And we have seen some negative trials that show inferior outcomes when everyone is deescalated. But what does remain promising is again, trying to select out who the best candidates are for deescalated treatment. The folks at MSK have hypoxia imaging that they're using in trials that looks quite promising to select for the more favorable deescalatable biology. At our center, we've been interested in using induction chemotherapy to stratify response and select patients for deescalated treatment with excellent survival outcomes and reduce toxicity with deescalated treatment. And more recently, ctDNA that us and other groups, such as the Dana-Farber group, is using. And that also looks quite promising. Again, how do you select the patient who will do well with less radiation versus the ones that really need the full doses and volumes of radiation? And then for HPV-negative head and neck cancer, this is a much trickier disease because already the survival outcomes are not like we want it to be. Trying to figure out how to improve survival outcomes remains an important thing. Using immunotherapy seems to be one of the key cornerstones to that. But these are patients that also suffer from a lot of toxicity related to their treatment. We completed a trial not too long ago that we published this past year where we, in HPV-negative head and neck cancer patients, de-intensified the radiation for responders to neoadjuvant chemoimmunotherapy. And those patients did similar, if not even a little bit better, than the non-responders who got full dose treatment. So something that does warrant further investigation as well. How do we not only improve survival for those patients, but also reduce some of the long-term toxicities? Dr. Monty Pal: This is brilliant. I'm taking so many notes as you were mentioning these items. There are so many areas where I think the research crosses over. I already mentioned, know, ctDNA, for instance, and metabolomics and the places where that might apply to kidney cancer. The hypoxia imaging really caught my ear too. Obviously, kidney cancer is disease highly predicated on hypoxia. So thank you for all of this. We've got about a minute or so. So, I'm going to ask you for a really tall task here. Can you tell us what you foresee being some of the biggest challenges that sort of lie ahead and head and neck cancer. You've already kind of alluded to it with ongoing research, but if you had to pick maybe 2, 3 problems, the very most that we really need to get to and head and neck cancer, what would that be? Dr. Ari Rosenberg: Yeah, that's a great question. Obviously, lots of things to be done, but if I'm going to limit it to just a couple, I would say number one is really trying to improve the survival for HPV negative local regionally advanced head and neck cancer. We talked early on about how we are seeing, you know, of course we see many of these people that were smokers and drinkers, but also seeing these in younger patients, in patients without a history of tobacco use. Some of these are very biologically aggressive and we need better treatments beyond surgery, beyond chemo radiation, beyond immunotherapy to improve outcomes for these patients and cure more of them. So, I would say that's one big area. And the other is, which we didn't speak about so much in this talk, but remains one of the biggest challenges that we see in the clinic is the recurrent metastatic head and neck cancer patients. This is an incredibly challenging disease to treat, not only with poor survival, but also with substantial impacts on quality of life and function. mean, these are bad recurrences that cause a lot of pain, functional deficits, really impacts quality of life as well. So developing novel therapies, many of which are currently in clinical trials and many of which are currently continuing to be developed, remains so critical. How do we develop better systemic therapies, better targeted therapies, better biomarkers for recurrent metastatic head neck cancer to improve their survival and quality of life and functional outcomes. Those are the two big areas that require the most work at this time within the head and neck cancer field. Dr. Monty Pal: That's brilliant. I mean, I have to tell you I could probably talk to you all day about this, such a fascinating topic. It's a very exciting time in the field. Thank you, Dr. Rosenberg, for all your incredible contributions and thanks for sharing with us your insights on the ASCO Daily News Podcast. Dr. Ari Rosenberg: Yeah, and thanks for the introduction. Hope to do it again soon. Dr. Monty Pal: And many thanks to our listeners for your time today. If you value the insights that you hear from the ASCO Daily News Podcast, please take a moment to rate, review, and subscribe wherever you get your podcasts. More on today's speakers:      Dr. Monty Pal   @montypal  Dr. Ari Rosenberg @AriRosenbergMD Follow ASCO on social media:           ASCO on X     ASCO on Bluesky          ASCO on Facebook           ASCO on LinkedIn           Disclosures:        Dr. Monty Pal:       Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview      Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical      Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis  Dr. Ari Rosenberg:     Stock and Other Ownership Interests: Privo Technologies Consulting or Advisory Role: Nanobiotix, EMD Serono, Vaccitech, Novartis, Eisai, Astellas Pharma, Regeneron, RAPT Therapeutics, Geovax Labs, Janssen, Summit Therapeutics Speakers' Bureau: Coherus Biosciences Research Funding (Inst.): Hookipa Biotech, EMD Serono, Purple Biotech, Bristol-Myers Squibb/Celgene, BeiGene, Abbvie, Astellas Pharma, Pfizer, Janux Therapeutics

This episode covers: Cardiology This Week: A concise summary of recent studies Atrial septal defects in adults Conservative and invasive management of chronic coronary syndromes Milestones: 4S trial   Host: Rick Grobbee Guests: JP Carpenter, Annemien van den Bosch, Rasha Al-Lamee, Roxana Mehran Want to watch the episode? Go to: https://esc365.escardio.org/event/2552 Want to watch the extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. Rasha Al-Lamee has declared to have potential conflicts of interest to report:speaker's fees for Menarini pharmaceuticals, Abbott, Philips, Medtronic, Servier, Shockwave, Elixir. Advisory board: Janssen Pharmaceuticals, Abbott, Philips, Shockwave, CathWorks, Elixir, Astrazeneca. Consulting Fees: Menarini pharmaceuticals, Abbott, Philips, Shockwave, Elixir, IsomAB, VahatiCor, SpectraWave, AstraZeneca, Cathworks, Janssen Pharmaceuticals. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Roxana Mehran has declared to have potential conflicts of interest to report: institutional research payments from Abbott, Alleviant Medical, Chiesi, Concept Medical, Cordis, CPC Clinical Research, Daiichi Sankyo, Duke, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Medtronic, NewAmsterdam Pharma, Novartis, Novo Nordisk Inc., Population Health Research Institute (PHRI), Protembis GmbH, Radcliffe, RM Global Bioaccess Fund Management, Sanofi US Services, Inc. ; personal fees from: None ; Equity

Host: Rick Grobbee Guest: Annemien van den Bosch Want to watch that extended interview on Atrial septal defects in adults, go to: https://esc365.escardio.org/event/2552?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2552 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina, Rick Grobbee, Nicolle Kraenkel and Annemien van den Bosch have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson

Adjuvant Therapy for Renal Cell Carcinoma Host: Mark L. Gonzalgo, MD, PhD, MBA Guest: Daniel Shapiro, MD, FACS CME Available: https://cme.auanet.org/Users/LearningActivity/LearningActivityDetail.aspx?LearningActivityID=4whvDiMGwrduRsuIIjUIxg%3d%3d ACKNOWLEDGEMENTS: Support provided by an independent educational grant from: Merck & Co., Inc. LEARNING OBJECTIVES: At the conclusion of this activity, participants will be able to: 1. Define adjuvant therapy, review current clinical guidelines, and recognize the current landscape of treatment options for patients with RCC. 2. Compare and contrast different adjuvant therapies available for RCC, including targeted therapies and immunotherapies. 3. Identify common side effects associated with adjuvant therapies for RCC and provide strategies for managing and mitigating these adverse events in clinical practice. 4. Discuss ongoing clinical trials and new therapeutic targets under investigation for adjuvant treatment of RCC.

Medical training is still stuck in the arcade era: expensive, basement-bound simulators and outdated software that rarely capture the real stakes of clinical decision-making. In this episode, host Alexandra Takei, Studio Director at Ruckus Games, sits down with Sam Glassenberg, founder of Level Ex (now part of Relevate Health), to unpack how game developers can modernize healthcare learning by truly embracing the craft of video game design, not “gamification” lipstick. The opportunity and the market here are much bigger than you might assume. Healthcare is a trillion-dollar industry in the US alone, and if you can create products that save the medical system money while also growing the $200B video game industry, that's a win-win. The conversation explores why even mediocre games outperform traditional training (the bar is shockingly low), and how live-ops principles let teams update clinical guidance fast. The pair also discusses who plays these games, and it turns out that it's not only doctors but “normal people” who have found these games on the app store. They go deep on design: mapping real clinical challenges to proven genres (diagnosis as reductive-reasoning puzzles, ventilators as rhythm games), and why domain experts often describe what's hard for residents, not what triggers adrenaline for experts, which is the source of “fun” in games. Finally, Sam breaks down the business: sponsored content by clients like Pfizer and Merck, free-to-play for doctors gameplay, and playable ads. We'd also like to thank Overwolf for making this episode possible! Whether you're a gamer, creator, or game studio, Overwolf is the ultimate destination for integrating UGC in games! You can check out all Overwolf has to offer at https://www.overwolf.com/.If you like the episode, please help others find us by leaving a 5-star rating or review! And if you have any comments, requests, or feedback shoot us a note at podcast@naavik.co. Watch the episode: YouTube ChannelFor more episodes and details: Podcast WebsiteFree newsletter: Naavik DigestFollow us: Twitter | LinkedIn | WebsiteSound design by Gavin Mc Cabe.

In this deeply moving episode of the Modern Mystic Soul Podcast, Therese is joined by Ksenia J. Merck, artist, architect, and creative storyteller whose life's work bridges structure, imagination, and spirit.After more than four decades leading large-scale airport design programs, Ksenia now brings her creative vision to emotional and cosmic landscapes through art and storytelling. Her latest project, Ghost Flower, is a genre-blending science-fiction novel written by her late husband, William F. Merck II, which Ksenia lovingly brought to life through illustration, completion, and posthumous publication.Set in the year 2035 during a global pandemic, Ghost Flower follows a team traveling back to 1585 to uncover the healing power of an ancient extraterrestrial flower, exploring themes of time, memory, leadership, love, and humanity's responsibility to future generations.Together, Therese and Ksenia explore:Completing a loved one's creative work as an act of devotion and healingThe transformative landscape of grief and finding purpose after lossArt as a bridge between memory, spirit, and meaningThe spiritual symbolism woven through Ghost Flower and its companion journalResilience, legacy, and love that transcends time and dimensionThis conversation is a gentle yet powerful reflection on how creativity can become a sacred path through sorrow—and how love continues to guide us long after physical presence fades.

"Brand is your story. That's the one thing that is unique about you." -Nick Usborne   Abe Kasbo is the Founder and CEO of Verasoni, a global marketing communications advisory and agency that delivers integrated strategies for Fortune 500, middle-market, and startup clients, and he serves as a trusted advisor to C-suite leaders on branding, communications, and public relations. He is the author of Irresponsibly Digital, a call to action challenging businesses to rethink digital-first strategies with greater purpose, creativity, and measurable impact, and he has been featured in major outlets including The New York Times, Forbes, PBS, and Fox Business. Abe is an award-winning entrepreneur and humanitarian, including the 2025 Small Business Council of America Humanitarian Award, a documentary filmmaker whose PBS-distributed film The Arab Americans explores 150 years of cultural impact, and a founder of multiple philanthropic initiatives. He is a Seton Hall University Entrepreneur Hall of Fame inductee and holds advanced degrees in public administration, political science, and international relations. Website: https://verasoni.com LinkedIn: https://www.linkedin.com/in/abe-kasbo-3828913/  YouTube: https://www.youtube.com/verasoni   Nick Usborne is a veteran copywriter, trainer, and digital marketing pioneer with over 40 years of experience helping brands and writers create clear, human-centered content. He trains digital marketers, copywriters, and content teams to protect authentic brand stories while using AI responsibly to generate content at scale, through his "AI + Emotional Intelligence" approach. Nick has written for global brands including Apple, Reuters, The New York Times, and Citibank, spoken at leading industry conferences, and led in-house trainings for organizations such as Intuit, Merck, and Walt Disney Attractions. He is widely recognized by industry leaders for his clarity of thought and continues to teach writers how to future-proof their work in the age of AI. Website: https://storyaligned.com/  LinkedIn: https://www.linkedin.com/in/nickusborne/    In this episode, we discover expert insights on blending AI, brand storytelling, and authentic marketing.   Apply to join our marketing mastermind group: https://notypicalmoments.typeform.com/to/hWLDNgjz   Follow No Typical Moments at: Website: https://notypicalmoments.com/ LinkedIn: https://www.linkedin.com/company/no-typical-moments-llc/ YouTube: https://www.youtube.com/channel/UC4G7csw9j7zpjdASvpMzqUA Instagram: https://www.instagram.com/notypicalmoments Facebook: https://www.facebook.com/NTMoments

"Brand is your story. That's the one thing that is unique about you." -Nick Usborne   Abe Kasbo is the Founder and CEO of Verasoni, a global marketing communications advisory and agency that delivers integrated strategies for Fortune 500, middle-market, and startup clients, and he serves as a trusted advisor to C-suite leaders on branding, communications, and public relations. He is the author of Irresponsibly Digital, a call to action challenging businesses to rethink digital-first strategies with greater purpose, creativity, and measurable impact, and he has been featured in major outlets including The New York Times, Forbes, PBS, and Fox Business. Abe is an award-winning entrepreneur and humanitarian, including the 2025 Small Business Council of America Humanitarian Award, a documentary filmmaker whose PBS-distributed film The Arab Americans explores 150 years of cultural impact, and a founder of multiple philanthropic initiatives. He is a Seton Hall University Entrepreneur Hall of Fame inductee and holds advanced degrees in public administration, political science, and international relations. Website: https://verasoni.com LinkedIn: https://www.linkedin.com/in/abe-kasbo-3828913/  YouTube: https://www.youtube.com/verasoni   Nick Usborne is a veteran copywriter, trainer, and digital marketing pioneer with over 40 years of experience helping brands and writers create clear, human-centered content. He trains digital marketers, copywriters, and content teams to protect authentic brand stories while using AI responsibly to generate content at scale, through his "AI + Emotional Intelligence" approach. Nick has written for global brands including Apple, Reuters, The New York Times, and Citibank, spoken at leading industry conferences, and led in-house trainings for organizations such as Intuit, Merck, and Walt Disney Attractions. He is widely recognized by industry leaders for his clarity of thought and continues to teach writers how to future-proof their work in the age of AI. Website: https://storyaligned.com/  LinkedIn: https://www.linkedin.com/in/nickusborne/    In this episode, we discover expert insights on blending AI, brand storytelling, and authentic marketing.   Apply to join our marketing mastermind group: https://notypicalmoments.typeform.com/to/hWLDNgjz   Follow No Typical Moments at: Website: https://notypicalmoments.com/ LinkedIn: https://www.linkedin.com/company/no-typical-moments-llc/ YouTube: https://www.youtube.com/channel/UC4G7csw9j7zpjdASvpMzqUA Instagram: https://www.instagram.com/notypicalmoments Facebook: https://www.facebook.com/NTMoments

Disclosures:Dr. Creech has disclosures of grant funding from NIH, CDC, Moderna, Pfizer and has been a consultant for Merck, Sanofi Paseur, TD. Cowen. Guidepoint Global, GSK, Delbiopharm, Dianthus, AstraZenecka and receives royalties from UpToDateWebsites:Philadelphia Children's Hospital Vaccine Education & ResourcesVUMC Children's Immunization GuideAAPRecommended Books:Anxious Generation: How The Great Rewiring of Childhood Is Causing an Epidemic of Mental Illness, Jonathan HaidtRighteous Mind: Why Good People Are Divided by Politics and Religion, Jonathan HaidtKey TakeawaysRSV prevention now includes both maternal vaccination during third trimester and monoclonal antibodies for infants, both showing 60-80% reduction in hospitalizationsHepatitis B vaccine is fundamentally a cancer prevention tool, and the birth dose is recommended at population level to prevent missed cases even when individual risk appears lowCocooning newborns through family immunization for influenza, pertussis, RSV, and measles is critical as community vaccination rates declineEffective vaccine conversations require avoiding shame and blame, expressing intellectual humility, asking "why" to understand concerns, and providing trusted resources rather than just educationThe future of vaccine development includes improved flu vaccines requiring less frequent administration, alternative delivery methods (intranasal, oral, microneedles), and advanced tools to understand rare adverse eventsWhile vaccine-preventable diseases like measles are increasing in pockets of under-vaccinated communities, maintaining high vaccination rates is essential to prevent widespread outbreaks of highly contagious diseasesParents face significant peer pressure around vaccine decisions, and healthcare providers should acknowledge this while modeling respectful dialogue with those who disagreeQuotable Moments"What is hepatitis B vaccine? It's a cancer prevention vaccine period. It prevents liver cancer. Why would I not want a cancer preventing vaccine?""An ounce of prevention is worth a pound of cure rather than knowing how to treat meningitis really effectively. Wouldn't it be great if we could prevent it all together?""I think we need to recognize that we probably want the same thing, except in extraordinarily weird situations. We both want the health of that child.""I recognize that there is still much to learn about these things, but here's where I land.""Vaccines and your baby's health, that's just more complicated than 140 characters.""Measles is the second most contagious virus on the planet behind smallpox, which is eradicated. So it's the first most...

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of significant shifts in the industry, marked by leadership changes, scientific advancements, strategic partnerships, and regulatory challenges.Starting with Sanofi, a notable leadership transition has taken place as Paul Hudson steps down from his role as CEO. Belen Garijo from Merck KGaA has stepped into this pivotal role. Her appointment is part of a broader industry trend toward diversifying leadership, especially with more women leading top-tier pharmaceutical companies. The implications of this shift could be profound for Sanofi, potentially stabilizing its operations and revitalizing its research pipeline. Stakeholders are keenly observing how this new leadership might steer Sanofi through complex market dynamics.In regulatory news, Moderna has encountered a significant hurdle with the FDA declining to review its next-generation mRNA flu vaccine. This decision has sparked an ongoing public dialogue between Moderna and U.S. health regulators, underscoring the complexities involved in navigating regulatory pathways for novel mRNA technologies beyond their initial success with COVID-19 vaccines. The Department of Health and Human Services has supported the FDA's decision, emphasizing the critical importance of meticulous scrutiny when it comes to new vaccine platforms. This development highlights the challenges biotech companies face in ensuring compliance with stringent regulatory standards.Financial updates reveal CSL experiencing a sharp decline in net profits, dropping from $2 billion to $384 million year-over-year. This financial downturn has been linked to strategic missteps or operational inefficiencies within the company, prompting a change in leadership. Such shifts reflect broader challenges faced by companies within the biotech sector as they strive to maintain financial stability amid fluctuating market conditions.In contrast, Alnylam Pharmaceuticals has reported its first profitable year despite underwhelming sales figures for its drug Amvuttra in the ATTR-CM market. This milestone is significant for Alnylam as it demonstrates resilience and the potential to pivot successfully amidst market uncertainties. However, the company will need to remain vigilant about revenue streams and market dynamics moving forward.Turning to advertising strategies, Johnson & Johnson's Tremfya continues to buck industry trends by maintaining a strong presence in television advertising through 2026. This strategy is noteworthy given the general decline in traditional media spending across the industry. J&J's commitment highlights its determination to sustain market share against competitors such as AbbVie's Rinvoq and Skyrizi.On the strategic front, Takeda Pharmaceuticals is consolidating its U.S. operations by reducing its Boston presence. By subleasing over 630,000 square feet of office space, Takeda aims to streamline operations and concentrate resources on key development projects at its new Cambridge hub. This move reflects broader industry trends towards operational efficiency and resource optimization.In clinical advancements, BridgeBio has reached a promising milestone with successful Phase 3 trial results for infigratinib in treating dwarfism. This breakthrough offers new therapeutic options for children affected by this condition and exemplifies ongoing innovations in genetic medicine. The success of this trial positions BridgeBio on a path toward regulatory approval, potentially transforming care for patients with limited treatment options.Agilent has achieved FDA approval for its companion diagnostic test alongside Merck's Keytruda for ovarian cancer treatment. This approval highlights the growing importance of precision medicine in oncology, where tailored treatments based on individual paSupport the show

In this podcast episode, Dr. Jonathan H. Westover talks with Alaina Love about her book, PERMISSION TO BE YOU: Discover Your Purpose And Passions To Bring Your Best Self To Everything – And Everyone. Alaina Love is CEO of Purpose Linked Consulting and a sought-after expert who coaches leaders and their teams on defining their purpose and using their passions to build healthy, productive workplaces and flourish in daily life. She is co-author of the bestselling book The Purpose Linked Organization and was formerly a research scientist and the executive director of global human resources at Merck & Co., Inc. Love is a graduate of the University of Michigan's Change Leadership Program, studied medicine at Tufts University School of Medicine, and holds a degree in medical technology from Monmouth University. Certified as a Senior Professional in Human Resources, Love is a member of Marshall Goldsmith 100 Coaches. An avid leadership thinker, she has written for Bloomberg Business Week, The Washington Post, and Harvard Business Review. Love lives in Raleigh, North Carolina.  Check out all of the podcasts in the HCI Podcast Network!

In this podcast episode, Dr. Jonathan H. Westover talks with Alaina Love about her book, PERMISSION TO BE YOU: Discover Your Purpose And Passions To Bring Your Best Self To Everything – And Everyone.Alaina Love is CEO of Purpose Linked Consulting and a sought-after expert who coaches leaders and their teams on defining their purpose and using their passions to build healthy, productive workplaces and flourish in daily life. She is co-author of the bestselling book The Purpose Linked Organization and was formerly a research scientist and the executive director of global human resources at Merck & Co., Inc. Love is a graduate of the University of Michigan's Change Leadership Program, studied medicine at Tufts University School of Medicine, and holds a degree in medical technology from Monmouth University. Certified as a Senior Professional in Human Resources, Love is a member of Marshall Goldsmith 100 Coaches. An avid leadership thinker, she has written for Bloomberg Business Week, The Washington Post, and Harvard Business Review. Love lives in Raleigh, North Carolina. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. In today's episode, we delve into the dynamic landscape of these industries, exploring ambitious strategic plans, regulatory hurdles, scientific breakthroughs, and emerging trends that are shaping the future of healthcare.Let's begin with AstraZeneca, which has set an ambitious target to achieve $80 billion in revenue by 2030. This goal reflects their intention to bring over 25 blockbuster drugs to market, underscoring a commitment to innovation and expansion in their therapeutic portfolio. The focus on cutting-edge research is not just a strategy for growth but also a sign of the broader industry trend where large pharmaceutical companies pursue high-value targets to strengthen their market positions. AstraZeneca is also making strides in the weight-loss market with its new candidate elecoglipron, undergoing an extensive late-stage program to evaluate its efficacy as a monotherapy and in combination treatments for various indications. This development positions AstraZeneca competitively in the burgeoning sector, offering a novel therapeutic option for obesity management.Meanwhile, CSL Limited is undergoing a leadership transition. CEO Paul McKenzie has stepped down under pressure, and Gordon Naylor has been appointed as interim chief. This change highlights the critical role of strategic leadership in navigating industry challenges and maintaining growth trajectories amidst a rapidly shifting market landscape.In a display of financial success, Novartis reported a record-breaking performance for 2025. This achievement led to a 30% increase in CEO Vas Narasimhan's compensation, reaching $32 million. The company's robust financial health is attributed to advancing innovative treatments targeting unmet medical needs, emphasizing how achieving innovation milestones can significantly enhance corporate valuation and leadership rewards.Incyte is preparing for the patent expiration of its blood cancer drug Jakafi in 2028 by focusing on Opzelura, a topical cream that has witnessed a 33% sales increase from the previous year. With sales reaching $678 million, Opzelura's success highlights Incyte's strategic pivot to diversify its product offerings and mitigate risks associated with patent cliffs. This exemplifies how companies must continuously innovate and adapt to maintain competitive advantages.Moderna has entered into a long-term agreement with Mexico to ensure local mRNA vaccine supply through technology transfer to Laboratorios Liomont. This partnership extends Moderna's global footprint and underscores the critical role of mRNA technology in pandemic preparedness and vaccine accessibility, reinforcing its transformative impact on public health strategies.Regulatory landscapes have also seen notable activity. The FDA issued untitled letters concerning potentially misleading drug advertisements from companies like Novo Nordisk, Argenx, and Sobi. Such actions emphasize regulatory vigilance in marketing practices. Additionally, Lilly's Kinsunla failed to secure approval in Scotland, while Regenxbio faced rejection for its gene therapy for Hunter syndrome. These regulatory hurdles highlight the rigorous oversight pharma companies face and the complex pathways drugs must navigate before market approval.Collaborations within the industry are proving crucial for innovation. Merck's collaboration with Calla Lily Clinical Care aims to enhance delivery systems for vaginal therapeutics. Similarly, Bristol Myers Squibb's partnership with Evinova focuses on integrating AI into clinical development processes. These alliances reflect an industry-wide emphasis on leveraging technology to improve drug delivery efficiency and streamline clinical trial operations.Shifting our focus now to scientific advancements and clinical trial results that aSupport the show

Can you really deliver speed, quality, and cost in construction—without tradeoffs? In this episode of Construction Genius, Eric Anderton sits down with Ryan Teicher, CEO of REDCOM Design & Construction, to unpack how a fully integrated design-build model eliminates silos, accelerates delivery, and aligns teams around client outcomes. Ryan explains how bringing architecture, engineering, estimating, and construction under one roof leads to faster decisions, fewer conflicts, and better cost control. The conversation dives into early design consulting as a risk filter, sales as true client advocacy, maintaining client intent from concept through construction, and why strong leaders must be willing to walk away from the wrong projects. This is a practical, no-BS conversation about design-build done right, along with CEO-level insights on leadership, culture, and scaling a construction company.  

What does it really mean to become unshakable when your career, your family life, and the world around you all feel uncertain at the same time? In this episode of Becoming Unshakable, I sat down with Christine Ann Miller for a conversation that stayed with me long after we stopped recording. From the very first question, Christine grounds resilience in something more profound than grit or endurance. She shares how becoming unshakable is tied to purpose, faith, and the courage to stay anchored to who you are, even when the path forward is unclear. Christine takes us through her journey as a Jamaican American leader, the first in her family born in the United States, and how growing up around healthcare shaped her desire to solve meaningful problems.  From discovering chemical engineering through an encyclopedia to interning at Merck and dedicating more than three decades to developing medicines that save and improve lives, her story is rooted in service, curiosity, and conviction. She reflects on why purpose matters more than titles and why alignment, not momentum, is what sustains a long career.   The heart of this episode centers on a defining crossroads. Christine shares what it was like to leave a senior role with no next job lined up, only to have the world shut down weeks later during the pandemic. We talk openly about fear, faith, rest, and the discipline of self-leadership when everything familiar disappears. She explains how grounding practices like prayer, meditation, journaling, community, and intentional rest helped her stay receptive to what came next, rather than rushing to force an answer. We also explore the role of support systems, from coaches and therapists to family and trusted friends, and why resilience is rarely built alone. Christine offers thoughtful guidance for anyone who feels like they are barely holding it together right now, reminding us that breathing, connection, service, and reflection are not small acts when life feels heavy. As you listen, consider where you might be rushing past the very pause that could help you hear what is next for you. When things feel shaky in your own life or leadership, what enables you to stay grounded long enough to recognize the opportunity that may already be on its way?  

Three years ago I interviewed my friend and occasional ACL contributor Gabe Bogart for Episode 29, our anniversary episode. We had such a good time we talked about doing a podcast called SLEPT ON IT, and so I sat on this episode for years, waiting for us to get off our asses and make it happen. No one ever asked why episode 30 was missing, so it feels right for an episode with this title to turn up years later. We discuss adventurous listening, the dangers of nostalgia, the hip hop renaissance of the 2020s, and much more. Happy Listening!Support: Patreon, PayPal, BandcampEpisode 30: SLEPT ON IT - with Gabe Bogart (or, BEATS RHYMES AFTERLIFE)Interview recorded between Montreal and Seattle, January 2023Produced and mixed in Montreal, June 2023 (and February 2026)LINKSEpisode 29 - CRITICAL POSITIVITYHip Hop Instrumentals Mix (Part I, Part II)Gabelicious Thee Most Delicious Mix Fart Un MixMurcof ~ The Alias SessionsTRACKLISTARTIST – “TITLE” (YEAR)Cannibal Ox (prod. by El-P), “Ox Out the Cage” (2002)SP INTROFranco Battiato, “Hey Joe” (2001)Os Mutantes, “Hey Joe” [1973] (1992)Robert Plant & Band of Joy, “Hey Joe (Live)” (2003)Lee Moses, Hey Joe (1971)Sparklehorse, “Hey, Joe” (1998)Jimi Hendrix, “Hey Joe” (1967)Armand Hammer (prod. Andrew Broder), “Frida (Instrumental)” (2023)Knxwledge (ft. Quelle Chris), “Ladibird” (2013)Jean Grae & Quelle Chris, “My Contribution To This Scam” (Everything's Fine, Mello, 2018)Quelle Chris, “Peace & Pain” (Lullabies For The Broken Brain, Mello, 2016)Dday One, “Mouth 2 Mouth” (Journal, Content (L)abel, 2009)Open Mike Eagle (prod. Quelle Chris), “Burner Account (feat. Armand Hammer)” (Component System With The Auto Reverse, Auto Reverse, 2022)Indelible MC's (prod. by El-P), “The Fire In Which You Burn (Instrumental)” (Fire In Which You Burn / Collude Intrude, Rawkus, 1997)billy woods (prod by Preservation), “Versailles (ft. Despot)” (Aethiopes, Backwoodz, 2022)Armand Hammer (prod by Messiah Musik), “Pakistani Brain”  (Rome, Backwoodz, 2017)Armand Hammer (prod. By August Fanon), “Microdose (feat. Quelle Chris)” (Rome, Backwoodz, 2017)Armand Hammer (prod. By The Alchemist), “Chicharonnes (feat. Quelle Chris)”  (Haram, Backwoodz, 2021)Quelle Chris, “DEATHFAME” (DEATHFAME, Mello, 2022)Metal Fingers, “untitled (meditation)” (Special Herbs Volume 9 & 0, Shaman Work, 2005)Dak, “Hunch” (Standthis, Leaving, 2009)Goodie Mob, “Free” (Soul Food, LaFace, 1995) Aesop Rock, “Button Masher (Instrumental)” (Spirit World Field Guide (Instrumentals), RhymeSayers, 2022)Outkast, “Rosa Parks (Instrumental)” (Aquemini (Instrumental), LaFace, 1998)DAK, “Rosaparks Is 12th St” (Youstandit / Leftrecord, Leaving, 2012)Outkast, “Chonkyfire” (Aquemini (Instrumental), LaFace, 1998)Good Mob, “I Didn't Ask To Come” (Soul Food, LaFace, 1995) Dak, “lookup”  (Standthis, Leaving, 2009)Public Enemy, “Rebel Without A Pause (Instrumental)” (Rebel Without A Pause, DefJam, 1987)Public Enemy, “Bring The Noise (No Noise Instrumental)” (Bring The Noise (No Noise Version), DefJam, 1987)RJD2, “Big Game” (In Rare Form (Unreleased Instrumentals), Bustown, 2004)Gravediggaz, “6 Feet Deep” (6 Feet Deep, Gee Street, 1994)Wu-Tang Clan (prod. by RZA), “Bring the Ruckus (instrumental)” [1993] (Enter The Wu-Tang (36 Chambers) Instrumentals, Loud, 2008)Raekwon Featuring Tony Starks  (prod. by RZA), “Criminology (instrumental)” (Criminology / Glaciers Of Ice, Loud, 1995)Viktor Vaughn (prod. By RJD2), “Saliva (Loop)”  (In Rare Form (Unreleased Instrumentals), Bustown, 2004)Deru, “I Don't Know You” (Trying To Remember, Merck, 2004)Deaf Center, “Time Spent” (Owl Splinters, Type, 2011)Svarte Greiner, “Devolve” (Devolving Trust, Miashmah, 2022)Murcof, “between thoughts” (The Alias Sessions, Leaf, 2021)Metal Fingers, “Camphor” (Special Herbs Vol. 7 & 8, Shaman Work, 2004)Blockhead, “Insomniac Olympics” (Music By Cavelight, Ninja Tune, 2004)

Jane Hyun is the leading authority for leveraging culture and differences to drive innovation. Often called an "interpreter," she has been a trusted coach for over 20 years to thousands of leaders at Fortune 500 companies including PepsiCo, Clorox, Merck, and USGA, as well as schools and nonprofits, guiding their growth by building their cross-cultural capability. She is the pioneering author of Breaking the Bamboo Ceiling: Leadership Toolkit for Asians and the co-author of Flex: The New Playbook for Managing Across Differences. Through her Cultural Fluency in Leadership Project, Jane enjoys helping leaders forge stronger teams by closing the gaps that get in the way of growth and collaboration.She has been featured on CNN, CNBC, and NPR and has written for Harvard Business Review, Forbes, Fast Company, and The Wall Street Journal on the topics of culture, career development, and onboarding. As a sought-after speaker, Jane has keynoted at Microsoft, ESPN, the International Coaches Federation (ICF), and the Conferences for Women. Recently, Jane received the Marshall Goldsmith 50 Leading Global Coaches Award as the #1 Coach for Cultural Fluency and the NAAAP Vision 100 Award.Her life's calling is to help others flourish in their workplaces and in their communities.In today's episode of Smashing the Plateau, you will learn how to build a meaningful, sustainable consulting practice by leveraging cultural fluency and staying true to your values.Jane and I discuss:Jane's career journey from corporate to consulting [03:02]How Jane developed her cultural fluency specialty [05:27]Assessing and improving cultural fluency in leaders [08:32]How Jane's business has evolved over 20 years [12:31]The importance of saying no to the wrong clients [14:45]The role of community and peer support in business growth [17:42]Integrating personal and professional life as an entrepreneur [19:35]The strategic importance of rest and self-care [22:11]Seeing growth as an iterative process [24:00]Learn more about Jane at: https://www.linkedin.com/in/jane-hyun?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app , https://www.instagram.com/janehyun_author/, and Substack ______________________________________________________________About Smashing the PlateauSmashing the Plateau shares stories and strategies from corporate refugees: mid-career professionals who've left corporate life to build something of their own.Each episode features a candid conversation with someone who has walked this path or supports those who do. Guests offer real strategies to help you build a sustainable, fulfilling business on your terms, with...

Treatment is a significant part of overcoming breast cancer, but what about the mental, physical and emotional challenges this disease presents? Sarah Cipolla and Tawana Davis both relied on their faith to get through breast cancer. Through it all – the ups and downs and good times and setbacks – they had hope for better days and trusted in their faith. Hope and faith are powerful forces during challenging times. Susan G. Komen leads Worship in Pink, a nationwide program that brings breast health education to faith communities. Through this effort, Komen can reach people who don't participate in breast health care and people who rely on their faith to overcome life's challenges. Thanks to Merck and Novartis for supporting the Worship in Pink Program

How do top sales leaders stay on top in 2026? Seasoned National Sales Director Kristy McCracken shares her secrets.About This EpisodeIn this episode of Medical Sales U, I sit down with Kristy McCracken, a veteran leader in medical devices and biologics. From managing multi-million dollar revenues to leading national teams at companies like Essity and Merck, Kristy knows what it takes to win.We dive deep into:The "Always Learning" Mindset: Why high-level executives are returning to the basics to stay competitive.Modern Networking: How to use LinkedIn and AI to find common ground with hiring managers today.Leadership & Coaching: Kristy shares a powerful story of how she coached an underperforming rep back to success.The Future of Med-Tech: Balancing high-tech AI tools with the "human touch" that closes deals.Whether you are trying to break into medical sales or you're a seasoned pro looking to reinvent your role, Kristy's insights on persistence and "sharpening the saw" are essential listening. Key Moments (Timestamps)00:00 – Introduction: The greatest winners never stop learning.02:15 – Kristy's journey: 20 years in Pharma and Medical Devices.04:30 – Why even National Sales Directors need a "Professional Community."07:45 – Breaking in vs. Leveling up: What has changed in 2026?11:10 – Leadership Deep Dive: Coaching a rep through a PIP (Performance Improvement Plan).15:30 – Networking Secrets: How Kristy landed her latest role using Dave's strategies.19:20 – The Human Element: Asking the "follow-up" question.23:10 – Advice for the next generation of medical sales leaders.Resources & LinksConnect with Kristy McCracken: https://www.linkedin.com/in/kristy-mccracken/READY TO BREAK INTO MEDICAL SALES? We help professionals transition into top-tier medical sales roles: medicalsalesu.com/Kristy mentioned that "Persistence is Key." What is the biggest rejection you've faced in your career, and how did you bounce back? Let us know in the comments!If you found value in this talk, please: SUBSCRIBE for more interviews with industry leaders. LIKE this video to help other medical sales professionals find us. HIT THE BELL so you never miss a coaching session.#MedicalSales #Leadership #CareerGrowth #SalesCoaching #MedTech #MedicalSalesU #Networking2026

Audio roundup of selected biopharma industry content from Scrip over the business week ended February 60, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – Merck looks to fill Keytruda's shoes; Novartis aims to push through largest expiry period; Novo warns of steep sales decline; Pfizer bullish on obesity; and Lilly expects orforglipron success. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-JES32O67YRBSLC6UV2JFY5KPBQ/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Dr. Pedro Barata and Dr. Ugwuji Maduekwe discuss the evolving treatment landscape in gastroesophageal junction and gastric cancers, including the emergence of organ preservation as a selective therapeutic goal, as well as strategies to mitigate disparities in care. Dr. Maduekwe is the senior author of the article, "Organ Preservation for Gastroesophageal Junction and Gastric Cancers: Ready for Primetime?" in the 2026 ASCO Educational Book. TRANSCRIPT Dr. Pedro Barata: Hello, and welcome to By the Book, a podcast series from ASCO that features compelling perspectives from authors and editors of the ASCO Educational Book. I'm Dr. Pedro Barata. I'm a medical oncologist at University Hospitals Seidman Cancer Center and an associate professor of medicine at Case Western Reserve University in Cleveland, Ohio. I'm also the deputy editor of the ASCO Educational Book. Gastric and gastroesophageal cancers are the fifth most common cancer worldwide and the fourth leading cause of cancer-related mortality. Over the last decade, the treatment landscape has evolved tremendously, and today, organ preservation is emerging as an attainable but still selective therapeutic goal. Today, I'm delighted to be speaking with Dr. Ugwuji Maduekwe, an associate professor of surgery and the director of regional therapies in the Division of Surgical Oncology at the Medical College of Wisconsin. Dr. Maduekwe is also the last author of a fantastic paper in the 2026 ASCO Educational Book titled "Organ Preservation for Gastroesophageal Junction and Gastric Cancers: Ready for Prime Time?" We explore these questions in our conversations today.  Our full disclosures are available in the transcript of this episode as well. Welcome. Thank you for joining us today. Dr. Ugwuji Maduekwe: Thank you, Dr. Barata. I'm really, really glad to be here. Dr. Pedro Barata: There's been a lot of progress in the treatment of gastric and gastroesophageal cancers. But before we actually dive into some of the key take-home points from your paper, can you just walk us through how systemic therapy has emerged and actually allowed you to start thinking about a curative framework and really informing surgery decision-making? Dr. Ugwuji Maduekwe: Great, thank you. I'm really excited to be here and I love this topic because, I'm terrified to think of how long ago it was, but I remember in medical school, one of my formative experiences and why I got so interested in oncology was when the very first trials about imatinib were coming through, right? Looking at the effect, I remember so vividly having a lecture as a first-year or second-year medical student, and the professor saying, "This data about this particular kind of cancer is no longer accurate. They don't need bone marrow transplants anymore, they can just take a pill." And that just sounded insane. And we don't have that yet for GI malignancies. But part of what is the promise of precision oncology has always been to me that framework. That framework we have for people with CML who don't have a bone marrow transplant, they take a pill. For people with GIST. And so when we talk about gastric cancers and gastroesophageal cancers, I think the short answer is that systemic therapy has forced surgeons to rethink what "necessary" really means, right? We have the old age saying, "a chance to cut is a chance to cure." And when I started out, the conversation was simple. We diagnose the cancer, we take it out. Surgery's the default. But what's changed really over the last decade and really over the last five years is that systemic therapy has gotten good enough to do what is probably real curative work before we ever enter the operating room. So now when you see a patient whose tumor has essentially melted away on restaging, the question has to shift, right? It's no longer just, "Can I take this out?" It's "Has the biology already done the heavy lifting? Have we already given them systemic therapy, and can we prove it safely so that maybe we don't have to do what is a relatively morbid procedure?" And that shift is what has opened the door to organ preservation. Surgery doesn't disappear, but it becomes more discretionary. Necessary for the patients who need it, and within systems that can allow us to make sure that we're giving it to the right patients. Dr. Pedro Barata: Right, no, that makes total sense. And going back to the outcomes that you get with these systemic therapies, I mean, big efforts to find effective regimens or cocktails of therapies that allow us to go to what we call "complete response," right? Pathologic complete response, or clinical complete response, or even molecular complete response. We're having these conversations across different tumors, hematologic malignancies as well as solid tumors, right? I certainly have those conversations in the GU arena as well. So, when we think of pathologic CRs for GI malignancies, right? If I were to summarize the data, and please correct me if I'm wrong, because I'm not an expert in this area, the traditional perioperative chemo gives you pCRs, pathologic complete response, in the single digits. But then when you start getting smarter at identifying biologically distinct tumors such as microsatellite instability, for instance, now you start talking about pCRs over 50%. In other words, half of the patients' cancer goes away, it melts down by offering, in this case, immunotherapy as a backbone of that neoadjuvant. But first of all, this shift, right, from going from these traditional, "not smart" chemotherapy approaches to kind of biologically-driven approaches, and how important is pCR in the context of "Do I really need surgery afterwards?" Dr. Ugwuji Maduekwe: That's really the crux of the entire conversation, right? We can't proceed and we wouldn't be able to have the conversation about whether organ preservation is even plausible if we hadn't been seeing these rates of pathologic complete response. If there's no viable tumor left at resection, did surgery add something? Are we sure? The challenge before this was how frequently that happened. And then the next one is, as you've already raised, "Can we figure that out without operating?" In the traditional perioperative chemo era, pathologic complete response was relatively rare, like maybe one in twenty patients. When we go to more modern regimens like FLOT, it got closer to one in six. When you add immunotherapy in recent trials like MATTERHORN, it's nearly triple that rate. And it's worth noting here, I'm a health services-health disparities researcher, so we'll just pause here and note that those all sound great, but these landmark trials have significant representation gaps that limit and should inform how confidently we generalize these findings. But back to what you just said, right, the real inflection point is MSI-high disease where, with neoadjuvant dual-checkpoint blockade, trials like NEONIPIGAS and INFINITY show pCR rates that are approaching 50% to 60%. That's not incremental progress, that's a whole new different biological reality. What does that mean? If we're saying that 50% to 60% of the people we take to the OR at the time of surgery will end up having no viable tumor, man, did we need to do a really big surgery? But the problem right now is the gold standard, I think we would mostly agree, the gold standard is pathologic complete response, and we only know that after surgery. I currently tell my patients, right, because I don't want them to be like, "Wait, we did this whole thing." I'm like, "We're going to do this surgery, and my hope is that we're going to do the surgery and there will be no cancer left in your stomach after we take out your stomach." And they're like, "But we took out my stomach and you're saying it's a good thing that there's no cancer." And yes, right now that is true because it's a measure of the efficacy of their systemic therapy. It's a measure of the biology of the disease. But should we be acting on this non-operatively? To do that, we have to find a surrogate. And the surrogate that we have to figure out is complete clinical response. And that's where we have issues with the stomach. In esophageal cancer, the preSANO protocol, which we'll talk about a little bit, validated a structured clinical response evaluation. People got really high-quality endoscopies with bite-on biopsies. They got endoscopic ultrasounds. They got fine-needle aspirations and PET-CT, and adding all of those things together, the miss rate for substantial residual disease was about 10% to 15%. That's a number we can work with. In the stomach, it's a lot more difficult anatomically just given the shape of people's stomachs. There's fibrosis, there's ulceration. A fair number of stomach and GEJ cancers have diffuse histology which makes it difficult to localize and they also have submucosal spread. Those all conceal residual disease. I had a recent case where I scoped the patient during the case, and this person had had a 4 cm ulcer prior to surgery, and I scoped and there was nothing visible. And I was elated. And on the final pathology they had a 7 cm tumor still in place. It was just all submucosal. That's the problem. I'm not a gastroenterologist, but I would have said this was a great clinical response, but because it's gastric, there was a fair amount of submucosal disease that was still there. And our imaging loses accuracy after treatment. So the gap between what looks clean clinically and what's actually there pathologically remains very wide. So I think that's why we're trying to figure it out and make it cleaner. And outside of biomarker-selected settings like MSI-high disease, in general, I'm going to skip to the end and our upshot for the paper, which is that organ preservation, I would say for gastric cancer particularly, should remain investigational. I think we're at the point where the biology is increasingly favorable, but our means of measurement is not there yet. Dr. Pedro Barata: Gotcha. So, this is a perfect segue because you did mention the SANO, just to spell it out, "Surgery As Needed for Oesophageal" trial, so SANO, perfect, I love the abbreviation. It's really catchy. It's fantastic, it's actually a well-put-together perspective effort or program applying to patients. And can you tell us how was that put together and how does that work out for patients? Dr. Ugwuji Maduekwe: Yeah, I think for those of us in the GI space, we have SANO and then we also have the OPRA for rectum. SANO for the upper GI is what takes organ preservation from theory to something that's clinically credible. The trial asked a very simple question. If a patient with a GEJ adenocarcinoma or esophageal adenocarcinoma achieved what was felt to be a clinical complete response after chemoradiation, would they actually benefit from immediate surgery? And the question was, "Can you safely observe?" And the answer was 'yes'. You could safely observe, but only if you do it right. And what does that mean? At two years, survival with active surveillance was not inferior to those who received an immediate esophagectomy. And those patients had a better early quality of life. Makes sense, right? Your quality of life with an esophagectomy versus not is going to be different. That matters a lot when you consider what the long-term metabolic and functional consequences of an esophagectomy are. The weight loss, nutritional deficiencies that can persist for years. But SANO worked because it was very, very disciplined and not permissive. You mentioned rigor. They were very elegant in their approach and there was a fair amount of rigor. So there were two main principles. The first was that surveillance was front-loaded and intentional. So they had endoscopies with biopsies and imaging every three to four months in the first year and then they progressively spaced it out with explicit criteria for what constituted failure. And then salvage surgery was pre-planned. So, the return-to-surgery pathway was already rehearsed ahead of time. If disease reappeared, take the patient to the OR within weeks. Not sit, figure out what that means, think about it a little bit and debate next steps. They were very clear about what the plan was going to be. So they've given us this blueprint for, like, watching people safely. I think what's remarkable is that if you don't do that, if you don't have that infrastructure, then organ preservation isn't really careful. It's really hopeful. And that's what I really liked about the SANO trial, aside from, I agree, the name is pretty cool. Dr. Pedro Barata: Yeah, no, that's a fantastic point. And that description is spot on. I am thinking as we go through this, where can this be adopted, right? Because, not surprisingly, patients are telling you they're doing a lot better, right, when you don't get the esophagus out or the stomach out. I mean, that makes total sense. So the question is, you know, how do you see those issues related to the logistics, right? Getting the multi-disciplinary team, getting the different assessments of CR. I guess PETs, a lot of people are getting access to imaging these days. How close do you think this is, this kind of program, to be implemented? And maybe I would assume it might need to be validated in different settings, right, including the community. How close or how far do you think you see that being applied out there versus continuing to be a niche program, watch and wait program, in dedicated academic centers? Dr. Ugwuji Maduekwe: I love this question. So I said at the top of this, I'm a health equity/health disparities researcher, and this is where I worry the most. I love the science of this. I'm really excited about the science. I'm very optimistic. I don't think this is a question of "if," I think it's a question of "when." We are going to get to a point where these conversations will be very, very reasonable and will be options. One of the things I worry about is: who is it going to be an option for? Organ preservation is not just a treatment choice, and I think what you're pointing out very rightly is it's a systems-level intervention. Look at what we just said for SANO. Someone needs to be able to do advanced endoscopy, get the patients back. We have to have the time and space to come back every three to four months. We have to do molecular testing. There needs to be multi-disciplinary review. There needs to be intensive surveillance, and you need to have rapid access to salvage surgery. Where is that infrastructure? In this country, it's mostly in academic centers. I think about the panel we had at ASCO GI, which was fantastic. And as we were having the conversation, you know, we set it up as a debate. So folks were debating either pro-surveillance or pro-surgery. But both groups, both people, were presenting outcomes based on their centers. And it was folks who were fantastic. Dr. Molena, for example, from Memorial Sloan Kettering was talking about their outcomes in esophagectomies [during our session at GI26], but they do hundreds of these cases there per year. What's the reality in this country? 70% to 80% to 90%, depending on which data you look at, of the gastrectomies in the United States occur at low-volume hospitals. Most of the patients at those hospitals are disproportionately uninsured or on government insurance, have lower income and from racial and ethnic minority groups. So if we diffuse organ preservations without the system to support it, we're going to create a two-tiered system of care where whether you have the ability to preserve your organs, to preserve bodily integrity, depends on where you live and where you're treated. The other piece of this is the biomarker testing gap. One of the things that, as you pointed out at the beginning, that's really exciting is for MSI-high tumors. Those are the patients that are most likely to benefit from immunotherapy-based organ preservation. But here's the problem. If the patient isn't tested at time of initial diagnosis before they ever see me as a surgeon, the door to organ preservation is closed before it's ever open. And testing access remains very inconsistent across academic networks. And then there's the financial toxicity piece where, for gastrectomy, pancreatectomy, I do peritoneal malignancies, more than half of those patients experience significant financial toxicity related to their cancer treatment. We're now proposing adding at least two years, that's the preliminary information, right? It's probably going to be longer. At least a couple of years of surveillance visits, repeated endoscopies, immunotherapy costs. How are we going to support patients through that? We're going to have to think about setting up navigation support, geographic solutions, what financial counseling looks like. My patient for clinic yesterday was driving to see me, and they were talking about how they were sliding because it was snowing. And they were sliding for the entire three-hour drive down here. Are we going to tell people like that that they need to drive down to, right, I work at a high-volume center, they're going to need to come here every three months, come rain or snow, to get scoped as opposed to the one-time having a surgery and not needing to have the scopes as frequently? My concern, like I said, I'm an optimist, I think it is going to work. I think we're going to figure out how to make it work. I'm worried about whether when we deploy it, we widen the already existing disparities. Dr. Pedro Barata: Gotcha, and that's a fantastic summary. And as I'm thinking also of what we've been talking in other solid tumors, which one of the following do you think is going to evolve first? So we are starting to use more MRD-based assays, which are based on blood test, whether it's a tumor-informed ctDNA or non-informed. We are also trying to get around or trying to get more information response to systemic therapies out of RNA-seq through gene expression signatures, or development of novel therapeutics which also can help you there. Which one of these areas you think you're going to help this SANO-like approach move forward, or you actually think it's actually all of the above, which makes it even more complicated perhaps? Dr. Ugwuji Maduekwe: I think it's going to be all of the above for a couple of reasons. I would say if I had to pick just one right now, I think ctDNA is probably the most promising and potentially the missing piece that can help us close the gap between clinical and pathologic response. If you achieve clinical complete response and your ctDNA is negative, so you have clinical and molecular evidence of clearance, maybe that's a low-risk patient for surveillance. If you have clinical complete response but your ctDNA remains positive, I would say you have occult molecular disease and we probably need intensified therapy, closer monitoring, not observation. I think the INFINITY trial is already incorporating ctDNA into its algorithm, so we'll know. I don't think we're at the point where it alone can drive surgical decisions. I think it's going to be a good complement to clinical response evaluation, not a replacement. The issue of where I think it's probably going to be multi-dimensional is the evidence base: who are we testing? Like, what is the diversity, what is the ancestral diversity of these databases that we're using for all of these tests? How do we know that ctDNA levels and RNA-seq expression arrays are the same across different ancestral groups, across different disease types? So I think it's probably going to be an amalgam and we're going to have to figure out some sort of algorithm to help us define it based on the patient characteristics. Like, I think it's probably different, some of this stuff is going to be a little bit different depending on where in the stomach the cancer is. And it's going to be a little bit more difficult to figure out if you have a complete clinical response in the antrum and closer to the pylorus, for example. That might be a little bit more difficult. So maybe the threshold for defining what a clinical complete response needs to be is higher because the therapeutic approach there is not quite as onerous as for something at the GE-junction. Dr. Pedro Barata: Wonderful. And I'm sure AI, whether it's digitization of the pathology from the biopsies and putting all this together, probably might play a role as well in the future.  Dr. Maduekwe, it's been fantastic. Thank you so much for sharing your insights with us and also congrats again for the really well-done review published.  For our listeners, thank you for staying with us. Thank you for your time. We will post a link to this fantastic article we discussed today in the transcript of this episode. And of course, please join us again next month on the By the Book Podcast for more insights on key advances and innovations that are shaping modern oncology. Thank you, everyone. Dr. Ugwuji Maduekwe: Thank you. Thank you for having me. Watch the ASCO GI26 session: Organ Preservation for Gastroesophageal and Gastric Cancers: Ready for Primetime? Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Follow today's speakers:          Dr. Pedro Barata   @PBarataMD    Dr. Ugwuji Maduekwe @umaduekwemd Follow ASCO on social media:          @ASCO on X (formerly Twitter)          ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Pedro Barata:   Stock and Other Ownership Interests: Luminate Medical   Honoraria: UroToday   Consulting or Advisory Role: Bayer, BMS, Pfizer, EMD Serono, Eisai, Caris Life Sciences, AstraZeneca, Exelixis, AVEO, Merck, Ipson, Astellas Medivation, Novartis, Dendreon   Speakers' Bureau: AstraZeneca, Merck, Caris Life Sciences, Bayer, Pfizer/Astellas   Research Funding (Inst.): Exelixis, Blue Earth, AVEO, Pfizer, Merck    Dr. Ugwuji Maduekwe: Leadership: Medica Health Research Funding: Cigna    

Bitcoin is crashing, tech and SaaS stocks are under pressure, and social media is full of panic but dividend investors are staying calm.In this episode, Derek and European DGI explain why this sell-off is sector-specific, not a market crash, and how dividend growth portfolios are holding up surprisingly well during volatility.We discuss:• Why Bitcoin's drop doesn't worry dividend investors• Sector rotation vs. real market crashes• What's happening to tech, SaaS, and AI-exposed stocks• Dividend hikes and earnings updates• How to stay rational when markets get noisyCompanies discussed include Microsoft, Shell, Novo Nordisk, Merck, Brookfield Asset Management, Hershey, PepsiCo, and more.We finish with a listener Q&A covering dividend cuts, price anchoring, currency risk, and investing during market drawdowns.

Day Two of our coverage of NCBA's CattleCon in Nashville and this morning's show is sponsored by Merck Animal Health. Joining us is National Cattlemen's Beef Association senior vice president of government affairs Ethan Lane and Jessica Lancaster, senior director of product quality & safety research at NCBA. Plus, Merck's message about dealing with New World screwworm.See omnystudio.com/listener for privacy information.

Dr. Monty Pal and Dr. Atul Batra discuss the PLANeT study from India, which evaluated low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer, and its place among a growing body of international research on improving efficacy while reducing costs and toxicity with lower doses of immunotherapy. TRANSCRIPT Dr. Monty Pal: Hello and welcome to the ASCO Daily News Podcast. I'm your host, Dr. Monty Pal. I'm a medical oncologist, professor, and vice chair of academic affairs at the City of Hope Comprehensive Cancer Center, Los Angeles. My guest today, I think, is going to be a really riveting one. It's Dr. Atul Batra, who is an additional professor of medical oncology at the All India Institute of Medical Sciences, or AIIMS, in New Delhi. And he's also the senior author of the PLANeT study. It's a very compelling study that evaluated low-dose pembrolizumab in addition to neoadjuvant chemotherapy for triple-negative breast cancer. And it's really a big part of a growing body of research that's showing balanced efficacy when we use lower doses of immunotherapy instead of standard doses to reduce cost, as well as potentially toxicity. I think this has huge implications for our global audience, and I'm so thrilled to have you on the podcast today, Dr. Atul Batra, welcome. Dr. Atul Batra: Thank you, Dr. Pal. Dr. Monty Pal: And we'll just take it with first names from here since we're both friends. I have to give the audience some context. Atul, I had the great honor of visiting AIIMS New Delhi. For those that don't know, this is really, you know, the Harvard Medical School of India. It's the most competitive institution for medical training. And on the back end of that, there's also incredible resources when it comes to clinical trials and infrastructure. I just wanted to have you give the audience sort of a scope of the types of trials that you've been able to do at AIIMS New Delhi. Dr. Atul Batra: Thank you, Monty. So, I work at the All India Institute of Medical Sciences, and we had the honor and pleasure of having Monty here this month. And people are still in awe of his lectures that he delivered there. Coming back to our institute, so it's kind of a medical college. It's one of the oldest ones, it was built in 1956. We are lucky enough that we get the best of the residents and fellows because they have to go through an exam, a competitive exam, and mostly it's them who come to us and we're able to do some good work out here. Regarding the trials that we have conducted, we do conduct some investigator-initiated studies, and we try to answer the questions where we can help our own patients. Like, for example, this PLANeT study. Every other patient in the clinic was almost not able to afford Keytruda at the full dose, pembrolizumab, and we had a lot of evidence creeping in that a lower dose might be helpful. And that's how we planned this study. Before that, there are certain cancers that are peculiar to India, like gallbladder cancer, head and neck cancers. These are much more common in India as compared to the U.S., and there are some good studies that have been conducted from our own institute by our senior colleagues which have been presented at ASCO and published in the JCO. We also did the capecitabine hand-foot syndrome study that was known as the D-ToRCH study: 1% diclofenac gel that became the standard of care to prevent hand-foot syndrome.  So, that's kind of a brief overview of investigator-initiated studies. India is slowly and steadily becoming a partner of the global registration trials. And it's more recently, the last five years or so, we have seen that the number of phase 2 and phase 3 trials are increasing and we are able to offer now these trials as well to our patients. Dr. Monty Pal: That was a terrific overview. I just want to highlight for the audience, as we go through some of your discussions today around specific trials, the speed at which this can be done. Just for context, for me to accrue a clinical trial of 30 patients – I think many people have probably come across some of the work that I've done in the microbiome space – at a single institution, 30 patients, right, takes me about a year and a half, two years. We're going to go through some trials today where Dr. Batra and his team have actually, in fact, accrued close to 200 patients over a span of just a year, which is just remarkable by, I would say, any American standard. So, I see a real need for partnership and Atul, I'll kind of get back to that at the end. But without further ado, the focus of this podcast today, I think, is really this terrific presentation you gave in an oral session at ESMO and subsequently published in Annals of Oncology related to the PLANeT study. Would you give the listeners some context around what the study entailed and population and so forth? Dr. Atul Batra: So, we know the KEYNOTE-522 became the standard of care for triple-negative breast cancer, where Keytruda, when added at 200 mg, the standard dose every three weeks with neoadjuvant, increases the pCR from around 51% to 64% by a magnitude of around 13%. However, in India and other low-middle income countries, less than 5% of the patients actually have access to this dose of pembrolizumab. So, our standard of care was actually just chemotherapy till now. And this kind of led us to design this trial. There are data that come from previous trials conducted in India, from the Tata Memorial, done in head and neck space, some other studies done in Hodgkin's lymphoma, that a much lower dose, probably around one-tenth of the dose, works well in these cancers. So, that's where we designed the PLANeT study, where we gave the standard neoadjuvant chemotherapy in the control arm, and in the experimental arm we added 50 mg of pembrolizumab. This was given every six weeks for three doses. So, that's a total of 150 mg over the neoadjuvant period as compared to 1,600 mg that was given in the KEYNOTE-522 study. So, this was almost one-tenth of the study. Dr. Monty Pal: So, a tenth of the dose, which is just remarkable. I mean, that's just such an interesting concept. Dr. Atul Batra: And the results, when we – the primary outcome, this was a phase 2 study. We just wanted to see, is there a signal of activity? And to even our surprise, when we looked at the pathological complete response rates, in the control arm this was 40.5%, and in the experimental arm this was 53.8%. So, a difference came to around 13.3%; it was numerically, I mean, so much similar to what KEYNOTE-522 had with just these many doses. So, this was around 160 patients randomized over one year. We could randomize them in one year because of the load that we see. And the primary endpoint was met, and we could see that the path complete response did show a remarkable increase. We are still following these patients to see whether there is a difference in event-free survival at a longer follow-up. Until now, it's a small follow-up, so the number of events absolute, are different: four events in the experimental arm and 11 events in the control arm. So, we are seeing some signal even in this much short follow-up period as well. But we need to see more of what happens in the longer term. Dr. Monty Pal: That's so impressive. I wonder, with this lower dose, do you attenuate toxicity at all as far as you can gather? Dr. Atul Batra: So, although we shouldn't be doing kind of cross-trial comparisons, but if you look at thyroid dysfunction, we saw that around 10% of our patients had this thyroid dysfunction. This was compared to 15% in the KEYNOTE-522, that was a larger sample size though. But we're seeing that all the toxicities are somewhat less as compared to those in the standard dose. So, the exposure is less, but I mean, I can't really commit definitely on this. For this we would need much more data to say this with more confidence. Dr. Monty Pal: Yeah. I'm going to ask you a really tough question to follow up, and this is probably something that's on everyone's mind after reading a study like this. Is this something that is disease-specific that needs to be replicated across other histologies? The reason I ask this is, you know, you think about paradigms like, for instance, in the States we're toying between intravenous versus subcutaneous delivery of checkpoint inhibitors, and we have studies focused in specific histologies that might justify use across all histologies. With this particular phenomenon, do you think we need to do dedicated studies in renal cell or in colon cancer and other places where, you know, in selected settings we might use checkpoint inhibitors and then decide whether or not there's this dose equivalence, if you will? Dr. Atul Batra: That's a real tough one, though. But I'm happy to share that there are several ongoing studies within India currently. At our institute, my colleagues are leading studies in lung cancer space, cervical cancer. There was already a publication from Tata Memorial Hospital in head and neck cancers and we see that the signal has been consistent throughout. Regarding renal cancer, there was one study that was presented for sure at ASCO from CMC Vellore, that's again a center in South India. That was in RCC at a much lower dose. And for patients who cannot take the full dose, we actually are offering lower dose nivolumab in such patients and we are seeing responses. I mean, we haven't done those randomized trials again because the numbers are much lower in kidney cancers, we know. We could do this trial in triple-negative ones because we had support and we had numbers to conduct this trial. But I'm sure this should be a class effect. I mean, when we can get tumor-agnostic approvals, then some real-world data has come up in almost all tumors, we have seen that consistent effect across tumors. And as we speak of today, I'm also delighted to share that in India, yesterday, we had the first biosimilar of nivolumab and that's now available at a much, much lower price than the original patent product. There was a long ongoing lawsuit that was there, that's over now, and from yesterday onwards, I'm so happy to share here that we would have the first biosimilar of nivolumab that's available. That's going to bring the cost to almost like one-tenth already. Dr. Monty Pal: Wow. That's huge.  I'm going to be very selfish here for a second and focus on a study that is in the renal cell space that your group has done. You know, when it came out, I was really sort of intrigued by this study as well and it reflects sort of a different capability, I think, of AIIMS New Delhi, and that's in the, what I'm going to call, biomarker space. This, for the audience, was a prospective effort to characterize germline variants in patients with advanced kidney cancer. And it's something that we talk about a lot in the kidney cancer literature, whether or not we're missing a lot of these so-called hereditary patterns of RCC. Can you tell us a little bit about that study too? Dr. Atul Batra: Yeah, so that was led by one of our fellows, Chitrakshi Nagpal, and she's just completed her fellowship. And two years back we published that. So, that was done in almost 160 consecutive patients that we recruited over the span of just one year and we saw, apart from the common known mutations in RCC, that was around 5% or so, but a lot of other mutations were also seen that we don't generally see in kidney cancers and we see in other cancers like BRCA1, BRCA2 and others. We are still, I mean, doing those analyses to see whether we get more things out of there in the somatic: is there a loss of heterozygosity or was it just present and in there? Dr. Monty Pal: I thought it was a terrific study and again, I was just so blown away at the pace. I mean, as I look at 140 patients accrued over a span of one year, this is something that would take us perhaps three times as long at City of Hope, and that's with a very sort of, what I consider to be large and dedicated kidney cancer program. So, it really underscores, I think, the need for collaboration. And ever since I came back from my visit to you at AIIMS Delhi, I think I've just been sort of transformed in the sense of trying to think of better ways for us to collaborate. One tangible thing that I'm going to get cracking on is seeing whether or not perhaps we can form some partnerships through SWOG or what we call the NCTN, the National Clinical Trials Network here within the U.S. Talk to me about collaboration. I mean, you've been really terrific at this. How do you sort of envision collaboration enhancing the global landscape of oncology? Dr. Atul Batra: That's really amazing, Monty. That's what we need. We have the infrastructure, we have the manpower, we have patients. I mean, these are all high-volume centers. Unfortunately, we are a little less in numbers, so we are more clinically occupied as well. So, sometimes it's kind of tougher, but again, when it comes to helping out the patients, global collaboration, we need to kind of take you guys along with us and have our patients finish trials earlier. This is a win-win situation for patients, one, because they also get exposure or an option to participate in the clinical trials, and second, we can answer all these scientific questions that we have at a much faster pace. All those things can be done within a much shorter span of time for sure. We are so happy to hear that, and with open hands we are ready to collaborate for all these efforts. Dr. Monty Pal: That's awesome. You know, I came back thinking, gosh, this would be so ideal for some of these rare subtypes of kidney cancer. Prospective clinical trials that I'm running in that space where really we're threatened with closure all the time. And if we just sort of extended a hand to, you know, our partners in India and other countries, you know, I'm sure we could get this research done in a meaningful way and that's got to be a win for patients. Atul, I had such a terrific time chatting with you today. I'm looking forward to seeing lots more productivity from your group there. By the way, for our viewership here, take a look and see what AIIMS New Delhi is doing under the leadership of Dr. Batra and others. It is just a real powerhouse and I think that after doing so, you'll be enticed to collaborate as well.  I'm hoping this is the first of many times that we have you on the podcast. Thank you so much for joining. Dr. Atul Batra: Thank you so much for having me here, Monty. It was a pleasure as always speaking to you. And thank you again. Dr. Monty Pal: You got it.  Well, and thanks to our listeners. I encourage you to check out Dr. Batra's paper. We'll actually have a link to the study in the transcript of this episode.  Finally, if you value the insights that you heard today on the ASCO Daily News Podcast, please rate, review, and subscribe wherever you get your podcasts. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers:     Dr. Monty Pal   @montypal Dr. Atul Batra @batraatulonc Follow ASCO on social media:          ASCO on X    ASCO on Bluesky         ASCO on Facebook          ASCO on LinkedIn          Disclosures:       Dr. Monty Pal:      Speakers' Bureau: MJH Life Sciences, IntrisiQ, Peerview     Research Funding (Inst.): Exelixis, Merck, Osel, Genentech, Crispr Therapeutics, Adicet Bio, ArsenalBio, Xencor, Miyarsian Pharmaceutical     Travel, Accommodations, Expenses: Crispr Therapeutics, Ipsen, Exelixis     Dr. Atul Batra: Stock and Other Ownership Interests: Zydus Pharmaceuticals, Glenmark, Caplin Point Laboratories, Laurus Research Funding: AstraZeneca, Astellas Pharma, Alkem Laboratories

Host: Emer Joyce Guest: Borge Nordestgaard Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Want to watch the full episode? Go to: https://esc365.escardio.org/event/2548 Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1. Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

This episode covers: Cardiology This Week: A concise summary of recent studies Lp(a) and aortic valve stenosis The truth about climate change and heart disease Snapshots Host: Emer Joyce Guests: JP Carpenter, Borge Nordestgaard, Hugh Montgomery, Stephan Achenbach Want to watch that episode? Go to: https://esc365.escardio.org/event/2548 Want to watch that extended interview on Lp(a) and aortic valve stenosis, go to: https://esc365.escardio.org/event/2548?resource=interview Disclaimer: ESC TV Today is supported by Novartis through an independent funding. The programme has not been influenced in any way by its funding partner. This programme is intended for health care professionals only and is to be used for educational purposes. The European Society of Cardiology (ESC) does not aim to promote medicinal products nor devices. Any views or opinions expressed are the presenters' own and do not reflect the views of the ESC. All declarations of interest are listed at the end of the episode. The ESC is not liable for any translated content of this video. The English language always prevails. Declarations of interests: Stephan Achenbach, Yasmina Bououdina and Nicolle Kraenkel have declared to have no potential conflicts of interest to report. Carlos Aguiar has declared to have potential conflicts of interest to report: personal fees for consultancy and/or speaker fees from Abbott, AbbVie, Alnylam, Amgen, AstraZeneca, Bayer, BiAL, Boehringer-Ingelheim, Daiichi-Sankyo, Ferrer, Gilead, GSK, Lilly, Novartis, Pfizer, Sanofi, Servier, Takeda, Tecnimede. John-Paul Carpenter has declared to have potential conflicts of interest to report: stockholder MyCardium AI. Davide Capodanno has declared to have potential conflicts of interest to report: Abbott Vascular, Bristol Myers Squibb, Daiichi Sankyo, Edwards Lifesciences, Novo Nordisk, Sanofi Aventis, Terumo. Emer Joyce has declared to have potential conflicts of interest to report: Alnylam, Bayer, Pfizer, Fire-1.  Konstantinos Koskinas has declared to have potential conflicts of interest to report: honoraria from MSD, Daiichi Sankyo, Sanofi. Felix Mahfoud has declared to have potential conflicts of interest to report: research grants from Deutsche Forschungsgemeinschaft (SFB TRR219), Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Herzstiftung, Ablative Solutions, ReCor Medical. Consulting fees, payment honoraria lectures, presentations, speaker, support travel costs: Ablative Solutions, Astra-Zeneca, Novartis, Inari, Recor Medical, Medtronic, Philips, Merck. Hugh Montgomery has declared to have potential conflicts of interest to report: funded and runs the charity-funded non-profit 'Real Zero'. Unpaid co-chair of the UK Health Alliance on Climate Change, Lancet Countdown on Health and Climate Change. Borge Nordestgaard has declared to have potential conflicts of interest to report: consultancies/talks for AstraZeneca, Sanofi, Ionis, Amgen, Amarin, Novartis, Novo Nordisk, Esperion, Lilly, Arrowhead, Marea, Merck, Torrent, USV – honoraria used for research. Steffen Petersen has declared to have potential conflicts of interest to report: consultancy for Circle Cardiovascular Imaging Inc. Calgary, Alberta, Canada. Emma Svennberg has declared to have potential conflicts of interest to report: Abbott, Astra Zeneca, Bayer, Bristol-Myers, Squibb-Pfizer, Johnson & Johnson.

Investors rotated out of technology stocks into shares more broadly linked to improvements in the economy, Merck was the biggest gainer in the Dow up 3.5 percent, More on the next Pints and Portolios this Saturday February 7th from 12 noon to 2pm with EP Wealth Advisors and Partners CFP Travis McEuen and CMT Nathan Rogers as well as Rob Black in Pleasant Hill with exact location given once you register

Investors rotated out of technology stocks into shares more broadly linked to improvements in the economy, Merck was the biggest gainer in the Dow up 3.5 percent, More on the next Pints and Portolios this Saturday February 7th from 12 noon to 2pm with EP Wealth Advisors and Partners CFP Travis McEuen and CMT Nathan Rogers as well as Rob Black in Pleasant Hill with exact location given once you registerSee omnystudio.com/listener for privacy information.

Audio roundup of selected biopharma industry content from Scrip over the business week ended January 30, 2026. This episode was produced with the help of AI text-to-voice and voice emulation tools. This time – AstraZeneca's big China investment pledge; Novartis exec's warning on early trial competitiveness; Chinese biotechs tap IPOs to fund foreign trials; Merck & Co on winning deals; and breaking down the India-EU free trade agreement. Story links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-T7BHL2UUN5DY3ENU5ZRTCY7YIE/ Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

From the JPM Healthcare Conference in San Francisco, Glenn Hunzinger brings together Sunil Patel of Merck and Sumit Khedekar of Citigroup for a conversation about where growth in the pharmaceutical and biotech industry is headed over the next five to ten years. They explore how scientific innovation, global sources of capital and talent, and a more forward looking approach to risk taking are shaping the future of healthcare, and why this moment may be pivotal for patients and the industry alike.Discussion highlights:Scientific innovation and unmet patient need remain the primary drivers of long term growth across pharma and biotechGlobal sources of innovation, including China, are reshaping licensing strategies and competitive dynamicsCompanies are increasingly willing to take calculated risk earlier in the drug development lifecycleValue creation depends on entering assets at the right inflection point rather than waiting for fully de risked launchesPayer dynamics, pricing pressure, and evolving consumer expectations are influencing how drugs are developed and commercializedSpeakers:Glenn Hunzinger, US Health Industries Leader, PwCSunil Patel, SVP, head of corporate development and business development & licensing, Merck Sumit Khedekar, Global head of Healthcare Investment Banking, CitigroupThis episode is also available as a video on our website: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast/where-will-growth-emerge-across-healthcare.htmlFor more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.